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Going Beyond Skin Deep When Managing Plaque Psoriasis

Wed, 12 Jan 2022 20:29:22 Z

Psoriasis (PsO) affects more than 8 million people in the U.S., and about 80-90% of them are diagnosed with plaque psoriasis. Despite the prevalence of the disease, there are still some factors patients may not understand about the condition, which affects everyone differently.

We sat down with Ponda Motsepe-Ditshego, vice president, Global Medical Therapeutic Area Head, to discuss the challenges people living with plaque psoriasis may face and how Amgen research is hoping to make an impact.

Plaque psoriasis is often downplayed or even dismissed by patients and the general public. What do you believe people, including patients, often misunderstand about plaque psoriasis?

Many people think plaque psoriasis is just an itchy skin rash, but in fact, it is a chronic (life-long), systemic, inflammatory disease. The symptoms of plaque psoriasis that you see on the outside of the skin are really caused by inflammation inside of the body. In other words, the itching, redness and burning typically associated with the disease are actually triggered by a dysfunction of the immune system.

Also, there is a large disease burden of plaque psoriasis on patients, which often goes far beyond physical symptoms. In addition to the symptoms that manifest on the skin, careful attention should be paid to less visible aspects of the disease. One of these “invisible” factors to consider is poor communication between patients and their physicians, which can be a major challenge around the treatment of plaque psoriasis. Patients sometimes struggle to express the effect of their plaque psoriasis on their daily lives, which can impact their doctor’s ability to fully appreciate how their disease creates barriers and challenges.

Plaque psoriasis is also a condition which can flare and subside in between doctor’s visits so it is important for patients to understand and take note of what they are experiencing and feeling so that they can fully explain the effect of the disease to their doctor. This way, their healthcare providers have a thorough idea of what the patient is facing when managing their disease.

There are several treatments available for plaque psoriasis, but many patients still have challenges getting their disease under control. Why is plaque psoriasis so difficult to treat?

Despite available treatment options, what works for one person with plaque psoriasis may not necessarily work for another. Plaque psoriasis is a heterogenous disease, which means it affects each patient differently.

Some individuals may develop plaques in areas that are difficult-to-treat, like the scalp, which may not be effectively treated with certain therapies. This makes it challenging to find a universal treatment that will work for all plaque psoriasis patients and is why it’s important for patients to follow up with their doctor when a treatment isn’t working.

What are some of the challenges healthcare professionals face when diagnosing and treating psoriasis?

There are many tools doctors use to measure the severity of plaque psoriasis. Doctors commonly categorize disease severity by evaluating the amount of body surface area (BSA) affected. What this clinical measurement does not capture is the variety of other factors and metrics that may impact the patient’s experience with their disease. The UPLIFT survey revealed that there is a disconnect between patients' perceptions and standard measures of disease severity that doctors rely on when treating patients.

Again, it’s important for patients to effectively communicate with their doctors so they can work together to find the treatment that’s right for them and potentially help to reduce their burden of the disease.

How is Amgen helping to make an impact in the psoriatic disease community?

As mentioned before, plaque psoriasis is complex, and to help address the disease, you need deep experience with it. We know many patients are still inadequately treated despite the number of available treatment options, and we are focused on finding options for these patients.

We have a depth of experience in inflammatory disorders, which positions us to understand the needs of people living with plaque psoriasis, and our experience in inflammation for over two decades gives us a unique perspective to be able to do so. Amgen recently conducted the global Understanding Psoriatic Disease Leveraging Insights for Treatment (UPLIFT) survey to better understand the evolution of attitudes and behaviors of patients living with psoriatic disease and their healthcare providers. Amgen is also actively working to try to address the underdiagnosis, underrepresentation and undertreatment of skin of color patients with psoriasis.

Further, our goal is to bring therapies to the millions of people with inflammatory diseases, and we hope to continue innovating in order to address unmet needs for patients and their loved ones.

To learn more about facts about plaque psoriasis see our article “7 Things About Psoriasis You Need to Know” in VeryWell Health.

Teneobio Acquisition Adds Talent and New Types of Antibodies to Amgen

Thu, 04 Aug 2022 04:21:18 Z

While multispecific medicines account for just a sliver of drugs now approved, most of Amgen’s early-stage pipeline consists of molecules directed at two or more targets. “The trend toward multispecific drugs is a wave that is sweeping across the entire industry,” said Ray Deshaies, senior vice president for Global Research. “We want to make sure that Amgen remains on the leading edge of that wave.”

Amgen’s expertise in this field has been strengthened by several key acquisitions. The BiTE^® (bispecific T cell engager) platform is an outgrowth of the 2012 acquisition of Micromet, now Amgen Research Munich. The 2019 acquisition of Nuevolution, now Amgen Research Copenhagen, added DNA-encoded library technology to accelerate our search for multispecific small molecules.

With the recently completed acquisition of Teneobio “we now have the most sophisticated tools available to generate the building blocks for large molecule multispecifics,” said Deshaies. “This technology isn’t only important for our T cell engagers but will benefit all of our therapeutic areas.”

“At Teneobio, we were committed to developing antibody therapies to improve the lives of patients and cure diseases,” said Katherine “Kat” Harris, who came to Amgen with the acquisition and is now vice president, Discovery. “As a small company, we already had more programs in our pipeline than we could take forward. With Amgen, we'll be able to deliver therapies at a pace and scale we couldn’t achieve on our own.”

From two chains to one

The Y-shaped antibodies produced by our immune systems have binding regions that match a specific shape. These shapes, called antigens, are usually segments of foreign or mutated proteins that are perceived as “non-self,” hence a threat. Drug designers can use the precision targeting provided by antibodies to engage many proteins involved in disease. However, it’s more difficult to make multispecific antibodies—one molecule that binds two or more antigens.

The challenge stems from the structure of antibodies, which are made up of light and heavy protein chains produced by two different genes. “When cells are assembling multispecific antibodies, the light and heavy chains don’t necessarily pair the way we want them to pair,” said Deshaies. “The cells tend to make a complete mélange of molecules with unpredictable properties.”

Protein engineers have devised clever ways to solve the mispairing problem, but implementing these solutions takes time, and the workarounds may not fix other issues. Teneobio has solved the mispairing problem through its UniRat^® technology. The platform is based on a genetically modified rat that produces fully human UniAb^® antibodies composed of a single heavy chain.

“A UniAb^® molecule acts just like an antibody—it is, in fact, an antibody—so it has the same extended half-life, and good manufacturability that comes with conventional antibodies,” said Harris. “These heavy chain-only antibodies offer unparalleled flexibility in terms of developing multispecific therapies. They also allow us to use sequence-based discovery to screen very large numbers of antibody genes very quickly to identify the best therapeutic candidates.”

Turning the tortoise into a hare

It’s difficult to use sequence-based discovery with conventional antibodies because the light and heavy chains have different genes. “If we just sequence all the antibody genes from an immunized animal, it’s hard to know which light chains go with which heavy chains,” said Alan Russell, vice president, Biologics. “By getting rid of the light chain, we can think about discovery in a digitally transformed way. We can turn the tortoise into a hare.”

Scientists at Teneobio have used sequencing to sort through large repertoires of antibody genes, group antibodies into related sequence families and rank those most likely to have high affinity for a target antigen. “It’s a simple equation,” said Harris. “The more abundant an antibody sequence is within a sequence family, the more likely it is that the antibody will be specific for its antigen.”

Sequencing can also pinpoint some potential limitations, such as amino acid sequences associated with less stable or hard-to-manufacture antibodies. By rapidly finding good binders and weeding out problems, sequence-based screening allows scientists to focus their lab-based testing on a smaller selection of high-quality molecules. It also accelerates the job of assembling binders, like beads on a string, into multispecific drug formats.

In the long run, this new technology opens the door to dramatic improvements by facilitating in silico drug design. “Eventually, we can use computers to help us make digital libraries of antibodies and then use those libraries to understand which sequences provide the best leads,” said Russell.

To make progress, in silico methods need to work hand-in-glove with lab work in an iterative cycle. Computers can predict the best antibodies based on their sequences; scientists can make and test those antibodies, and the results can inform machine learning models and sharpen the accuracy of future predictions.

“The heavy chain-only platform will allow us to do in silico library design, which has the potential to reduce by as much as two-thirds the time it will take to develop leads and hand them off to the teams that see if those leads actually help patients,” said Russell. “That’s why we are so excited about the platform.”

New options for T cell engagers

Another Teneobio innovation could expand the therapeutic potential of Amgen’s bispecific T cell engagers. T cell engagers are designed to direct the power of the immune system against cancer by directly linking T cells to tumor cells. In some patients, the resulting immune response can lead to a cascade of events, called cytokine release syndrome (CRS), that impact normal tissue as well. While CRS can be mitigated by anti-inflammatory drugs and modified dosing regimens, these measures may reduce or delay a drug’s treatment benefits.

Teneobio has engineered a T cell engager that binds with a very low affinity to the CD3 receptor on T cells. Both high- and low-affinity T cell binders are needed in cancer therapy. Some cancer patients benefit from higher potency, even if it comes with higher cytokine release, while other patients require lower risk of CRS, even if it comes with lower potency. The addition of Teneobio will help Amgen optimize our molecules and provide the right CD3 engager for the right target, the right tumor, and the right patient.

In his comments on the day that Teneobio staff joined Amgen, Deshaies emphasized that the new combined team will be pursuing a highly ambitious research agenda.

“We are not just trying to make a few medicines, which is obviously important in and of itself. We are trying to come up with a whole new class of medicines that will completely reshape how we think about treating patients. That’s incredibly exciting.”

Amgen Plugs In: Electric Vehicle Pilot Program Advances Carbon Neutrality Goal

Fri, 25 Feb 2022 18:54:54 Z

Brent Meeks spends most of his workdays with Amgen behind the wheel of a car. As a senior specialty sales representative in Northern California, he visits physicians as much as two hours away from his home across a large rural territory that stretches from Yreka to Davis, California. When he received an email asking for volunteers to join a new electric vehicle pilot program for Amgen’s field fleet, the self-described “car and technology nerd” jumped at the chance to take part.

“When Amgen announced last year that the company would become carbon neutral by 2027, my immediate thought was about the carbon footprint of the sales force and their vehicles,” Meeks says. “I was excited to join the pilot program because I know electric vehicles are the future. Along with the sustainability benefits, they’re fun to drive!”

Amgen’s minimum 30% electrification target will significantly reduce carbon emissions

In the U.S., Amgen’s field staff includes sales representatives and medical liaisons who drive long distances for business. Globally the field fleet represents around 15% of the company’s overall carbon footprint, making the field fleet the third largest contributor of carbon emissions, only behind Amgen’s two largest manufacturing facilities in Juncos, Puerto Rico, and Thousand Oaks, Calif.

“Adapting to cleaner technologies such as all-electric vehicles is critical,” says Yanina Barrera, Ph.D., principal engineer, Engineering Technical Authority, who leads Amgen’s sustainability efforts to increase electrification of the field fleet to at least 30%. “Although carbon is emitted to the atmosphere indirectly from charging, all-electric vehicles often provide the largest reductions in carbon emissions in comparison to conventional fossil fuel internal combustion engine vehicles in countries like the U.S., Netherlands, and South Korea.”

For Jill Garand, senior specialty sales representative in the Anaheim territory of Southern California, getting in on the ground floor of this new program at Amgen was an easy choice. “This is the wave of the future. Where I live in California, you already see electric vehicles everywhere,” she says. “Now that I drive an electric vehicle for work, it feels like I’m doing my part for the environment. Amgen is such a progressive company—this seems like a natural thing to do.”

A better—and more sustainable—driving experience

Launching Amgen’s electric vehicle pilot program in the U.S. was no easy task. It started by developing a cross-functional fleet team to address key challenges, including the lower mileage range of electric vehicles paired with limited charging infrastructure availability in some territories, the lack of available vehicles due to supply chain issues, and the need to recruit volunteers for the pilot program.

“To ensure business continuity, Amgen covered the cost of home charger installation so the field staff can charge their vehicles at home overnight,” Barrera explains. “We also launched driver workshops to provide necessary information around common issues like public charging stations and reimbursement processes for electricity usage."

Both Meeks and Garand say that making the switch to their electric vehicles (both are driving the Volvo XC40 Recharge) was not only easy, but also that the experience of driving the cars has been fun, and they quickly noticed significant cost savings.

“By my calculations, I’ve figured that in the 9,000 miles I’ve driven the car, I’ve saved about 50% of what Amgen would be paying for gas for the same mileage, not to mention there’s no oil changes or maintenance costs,” Meeks says. “I also just look forward to driving the car. It’s fun, it’s high tech, and it puts a smile on my face every time.”

“Even having to stop at a charging station for 30 minutes during the day became a positive change to my way of working,” Garand says. “It gives me time to catch up on the administrative work that I used to end up doing in the evenings because I was always on the move during the day.”

Pilot program is on the road and off to a strong start

The goal of Amgen’s first electric vehicle pilot program is to capture lessons learned in preparation for launching a minimum of 1,800 electric vehicles on the road by 2027. “It will take global participation to help Amgen reach carbon neutrality by 2027,” Barrera says, “and electrifying our fleet in countries that are ready is critical to making that happen.”

As of January 1, 2022, Barrera's team has placed orders for 195 electric vehicles, which have been assigned to field staff, and that there are currently 105 Amgen field staff in the U.S. driving electric vehicles for work. Planning is also underway for deployment of all-electric vehicles in other geographies, including, but not limited to, the Netherlands and South Korea.

“Most importantly, this voluntary pilot program is empowering field staff to help us reach our carbon neutrality goal, and it’s integrating a culture of environmental sustainability throughout our business,” Barrera says. “I'd like thank my colleagues for the enormous efforts over the past year to help launch this program and achieving the 2021 environmental sustainability goal of 100 electric vehicles on the road in the midst of vehicle shortages and other global supply chain issues.”

Learn more about Amgen’s 2027 Environmental Sustainability Plan.

Harnessing the Power of Collaborations to Improve Cardiovascular Health

Thu, 10 Mar 2022 22:44:16 Z

The Robert Wood Johnson Foundation (RWJF) noted in a recent report that building a national culture of health will take "collective engagement and unprecedented coordination between the public and private sectors."

Amgen is an advocate of this approach, especially for tackling the biggest and most complex health challenges facing patients and societies around the world. That is why we both support independently led initiatives and forge strategic collaborations with other organizations.

There is no better time than American Heart Month to hear from experts at organizations that Amgen supports and works with about how collaborations are making a difference in improving heart health of the communities they serve.

Joining us for this conversation are:

Dr. Michelle Albert
President
Association of Black Cardiologists

Dr. Eduardo Sanchez
Chief Medical Officer for Prevention
American Heart Association

Dr. Lisa Waddell
Chief Medical Officer
CDC Foundation

Katherine Wilemon
Founder and Chief Executive Officer
Family Heart Foundation

Why are collaborations important in addressing major public and population health challenges, particularly cardiovascular disease, in the communities you serve?

Dr. Waddell: Public health professionals have been fighting cardiovascular disease for a long time, making tangible progress along the way. But we are seeing some concerning plateaus and even some declines in that progress. According to the CDC, nearly half of Black men and women in the United States are living with some form of cardiovascular disease. Collaboration is more important than ever because by working together we can create innovative strategies to engage individuals and communities in ways that will drive meaningful action.

Dr. Sanchez: Too many organizations are working in isolation from one another. Building more powerful public-private healthcare partnerships is vital to moving the needle in addressing public and population health challenges. The American Heart Association works with several community organizations, individual ambassadors, and strategic alliances to harness innovation, disrupt the status quo, and effect system change to ensure equitable health for all.

Dr. Albert: Local and industry collaborations, like the one between the Association of Black Cardiologists and Amgen, are essential to our ability to plan and implement our innovative models of health education. They are also key to our ability to evaluate their success in increasing awareness of cardiovascular-related diseases and their prevention for the populations in the diverse communities we serve.

Ms. Wilemon: Effective structural and personal solutions to pervasive healthcare challenges, like managing and preventing heart disease, require that everyone do their part. Solutions must work at many levels and for diverse groups. Multi-stakeholder collaborations are our best way to find the strongest solutions.

Tell us about the focus and goals of your organization's heart health campaign.

Dr. Sanchez: Only 20% of a person's health is shaped by access to quality health care, but where a person lives could cost them up to two decades of life. The American Heart Association is working to support community transformation through educational outreach. Our vision is to meet people where they are and empower them to take action. Our EmPOWERED to Serve health lessons engage and support local community members to create a culture of health.

Dr. Albert: At the heart of the Association of Black Cardiologists is our unwavering commitment to improving cardiovascular health outcomes in the most underserved and disproportionally impacted communities. Our Spirit of the Heart initiative encourages community-wide participation at every level of our heart disease and stroke education, detection and prevention efforts. Spirit of the Heart helps community members understand that heart disease is preventable, and heart healthy practices are important for longevity and quality of life.

Ms. Wilemon: The vast majority of people who have a genetic driver of their cardiovascular risk have not been diagnosed and therefore are not getting the care they need. For the Family Heart Foundation those are people with the genetic disorders Familial Hypercholesterolemia (FH) and/or elevated Lipoprotein(a), many of whom are already living with heart disease. Our More Families, More Hearts campaign connects the dots between cardiovascular disease and high cholesterol that "runs in the family" and how to get an actual diagnosis and appropriate, timely management. What is particularly important about this campaign is that we will identify entire families and be able to help them with tools to address this genetic risk and prevent cardiovascular disease.

Dr. Waddell: Live to the Beat, which is part of the CDC Foundation's Alliance for the Million Hearts^® Campaign, focuses on helping people understand their personal risk for heart disease and stroke, believe in their power to change it and take steps that lower their risks. At its core, this is a belief change campaign. We have seen great progress with prior campaigns that have similar goals. Live to the Beat builds on that progress – inspiring Black adults who have cardiovascular disease risk factors, in particular, to positively believe they can be successful and to have confidence in their ability to overcome their barriers to heart-healthy living.

Your initiatives are very interactive, encouraging both communities and individuals to take actions toward better heart health. Can you talk about what makes your approach unique?

Dr. Albert: Spirit of the Heart is anchored by a three-part strategy to engage the community at all levels. Our Community Leaders' Forum engages civic, religious, nonprofit, grassroots advocacy, education and healthcare leaders to discuss the cardiovascular health of the local community. Together, they identify risk reduction strategies and commit to a "call to action" to improve community health, including ensuring equal access to care and resources for all. Our Message from the Pulpit program works with local faith-based leadership to provide congregational messages based on the ABC's "7 Steps to a Healthy Heart" which was first introduced by the organization in 2001. Lastly, we hold community-wide health fairs where ABC-trained health advocates and local partners provide free health screenings to assess heart disease and stroke risk factors.

Ms. Wilemon: Over our first 10 years, we built easy to understand educational tools and easy to access support resources to help people navigate their journey. It is stressful to need a surgery or to discover that your child has inherited a genetic condition from you. Our Care Navigation Center helps people as they discover their diagnosis, connecting them with a specialist, providing resources to understand their treatment goals and options, and helping them to navigate access to care. We also help people inform their family members of the need to be screened and connect those who reach out to us with a knowledgeable and welcoming community of people who share their experience, including our volunteer peer support network. The More Families, More Hearts Campaign leads people to the resources they need at a time when our healthcare system places more and more responsibility on patients to navigate their own care. We help make sure they don't have to do that alone.

Dr. Waddell: Live to the Beat reflects a unique approach in cardiovascular disease communication campaigns. The key is that we included the perspectives of Black audiences, via focus groups, surveys and research, in creating our resources. The campaign's messages reflect what we heard, featuring: (1) strong empathy tones – acknowledging that the behaviors we're promoting aren't always easy and it's ok if it takes you some time to build new habits; (2) focus on living – emphasizing how cardiovascular disease prevention can improve your living and your quality of life rather than leading with the statistics about your chance of dying; and (3) emphasis on small steps – providing small step examples and solutions to reinforce that prevention is doable, one step at a time.

Dr. Sanchez: EmPOWERED to Serve is inspired by American Heart Association volunteers around the country who are passionate about driving change through health justice and community empowerment. Communities need the localized solutions and resources EmPOWERED to Serve provides to help individuals and families achieve longer, healthier lives. The community knows best which changes are needed to achieve best health for all. We amplify these community-centered solutions to make measurable impact on eliminating health disparities and moving toward health equity through improvement of social determinants of health.

Collaboration fosters bold solutions to improve public, community and individual health

Amgen is proud to work with the American Heart Association, Association of Black Cardiologists, CDC Foundation and the Family Heart Foundation and thanks the visionary leaders who took the time to talk about their work to improve patient outcomes and well-being.

Amgen Oncology Supports Closing the Cancer Care Gap This World Cancer Day

Fri, 04 Feb 2022 14:49:14 Z

This World Cancer Day, Amgen Oncology is joining the Union for International Cancer Control’s (UICC) call to “Close the Care Gap” in cancer care. We live in a time of rapid innovative advances in cancer prevention, diagnosis and treatment; however, many people with cancer continue to face barriers to receiving care along their journey. Long-standing health inequities such as access to care, geographical location and income, as well as discrimination based on ethnicity, gender, sexual orientation, age, disability and lifestyle are just a few of the factors that can negatively affect cancer care.

We work hard to address inequities in healthcare, but it’s not a simple problem to solve as the causes of those inequities are multifactorial. Closing gaps in cancer care isn’t about simply providing patients with equal resources, because one size does not fit all and every challenge demands an adequate, and often personalized, solution.

— I-Fen Chang, VP, Global Therapeutic Area Head at Amgen

The work Amgen staff and partners around the world are doing underscores our commitment to closing the care gap. Amgen Netherlands is shining a light on stem cell donations through the AmgenCare donor program which was created to help cancer patients with stem cell transplantations. The program helps to reduce the burden on the donor and provides more flexibility in the planning of donations and stem cell procurement, which results in an increase in stem cell transplants.

The AmgenCare donor program was created to help reduce the burden on stem cell donors and provide more flexibility in the planning of donations and stem cell procurement, which results in an increase in stem cell transplants.

Additionally, Amgen Netherlands participated in the Eleven Cities Cycling Tour to raise funds for the Dutch Centre for Stem Cell Donors which helps to register new donors. Some Amgen volunteers participated in the cycling portion, while others staffed a booth recruiting people to register as a donor during the event. Through initiatives like the donor program, Amgen is taking steps to help make healthcare accessible and inclusive.

Amgen Netherlands participated in the Eleven Cities Cycling Tour to raise funding for the Dutch Centre for Stem Cell Donors to register new stem cell donors.

In the U.S., to recognize ethnic diversity and show support for minority populations who are disproportionally affected by cancer, Amgen’s Black Employee Network (ABEN) will partner with the National Breast Cancer Foundation (NBCF) to host a breast cancer informational webinar as part of their Black History Month activities for Amgen employees.

Amgen employees around the globe understand the importance of addressing health inequities from a company level, but also on a personal level. This rings true for U.S. Amgen employee Mel Piasecki who in 2015 was diagnosed with chordoma, a rare form of cancer, while pregnant. After giving birth, Mel and her family moved to Christopher’s Haven in Boston to get proper treatment at Massachusetts General Hospital. Christopher’s Haven is a non-profit organization providing housing support for those who would otherwise not be able to afford travel to and receive care at Massachusetts General Hospital. Each year Mel’s family goes back to Boston to volunteer at the fundraising event “Cape Cod Bay Challenge” which helps to raise awareness about the organization.

Mel Piaseck at the “Cape Cod Bay Challenge” to help raise awareness around Christopher’s Haven, a non-profit organization offering housing and support for families dealing with cancer.

World Cancer Day is a powerful reminder that we all have a role in helping reduce the impact of cancer in our communities, while supporting those who have been impacted by this disease. We hope you will join us this #WorldCancerDay to learn more about how we can all help to #CloseTheCareGap. Be sure to visit our Twitter page to see how you can get involved in World Cancer Day, like signing the Close the Care Gap pledge.

Recognizing Black History Month's Focus on Health and Wellness

Fri, 25 Feb 2022 18:47:00 Z

Amgen is proud to support February’s Black History Month, which focuses on a unique theme every year. This year’s − Health and Wellness – is particularly timely as the pandemic continues to negatively affect health outcomes, specifically for BIPOC (Black, Indigenous and People of Color) communities.

We’ve bundled available resources here on this page that support this year’s theme of Black Health and Wellness, including articles about the importance of clinical trial diversity (and how Amgen is addressing this), why community partnerships are key to disrupting health barriers and what needs to be done to continue to advance our diversity, inclusion and belonging journey. We invite you to read these articles as well as ones providing health information on biomarker testing, severe asthma, bone health, plaque psoriasis and heart health.

Inside Amgen’s Push for Greater Diversity in Clinical Trials

Through an internal program known as RISE (Representation in Clinical Research), Amgen is looking to create greater equity related to clinical trial diversity.

Building Partnerships to Disrupt Health Barriers

5 Lessons from Amgen’s 8th Annual Health Equity Summit.

Candid Conversations: Amgen Black Employee Network (ABEN)

In celebration of Black History Month, the first video features transparent dialogue between David Reese, executive vice president, R&D and executive sponsor of the Amgen Black Employee Network (ABEN), and Mike Edmondson, a vice president in our Global Commercial Organization and immediate past global chair of ABEN.

4 Questions About Biomarker Testing and the Critical Role It Plays in NSCLC

Biomarker testing at the time of diagnosis is a critical first step in getting patients on the right treatment plan.

Can You Answer These 6 Questions About Severe, Uncontrolled Asthma?

Learn more about this serious condition that affects millions of people around the world.

4 Ways Amgen Is Working With Organizations to Improve Osteoporosis Care and Bone Health

As the U.S. recognizes the month of May as osteoporosis awareness month, Amgen remains committed to predicting and helping prevent the impact of serious diseases like osteoporosis.

Going Beyond Skin Deep When Managing Plaque Psoriasis

Alliance for the Million Hearts Campaign Aims to Prevent One Million Heart Attacks and Strokes by 2022

Amgen has joined CDC Foundation and others in coalition to fight cardiovascular disease.

The Transformation of Amgen’s Black Employee Network: How to Impact the Business in Six Steps

Amgen’s Black Employee Network (ABEN) is a global community helping to recruit talent, develop leaders and impacting the way we ensure our medicines serve our diverse patients. Here’s how they got there.

Fellowship Program Between Amgen and Howard University Aims to Expand Talent Pool

Partnering with Historically Black Colleges and Universities will help broaden Amgen’s staff with new scientists, making the company stronger as it continues its quest to fight diseases.

Diversity, Inclusion and Belonging

Diversity matters at Amgen. We believe that an environment of inclusion fosters innovation, which drives our ability to serve patients. Our global presence is strengthened by having a workforce that reflects the diversity of the patients we serve.

COVID-19 Information Center

As the COVID-19 global pandemic continues to evolve, we are committed to doing everything we can to deliver for patients, to keep our staff and their families safe, and to help the communities where we live and work reduce the number of people exposed to the virus.

The Journey from Patient to Scientist: A Q&A with Dr. Primal Kaur

Fri, 25 Feb 2022 20:20:49 Z

In this Q&A, Amgen’s Dr. Primal Kaur talks about her experience living with severe asthma as a child and how it influenced her life and career as a physician scientist.

Dr. Primal Kaur, M.D., MBA, physician scientist and vice president of Global Development, Inflammation, has made it her life mission to support people living with chronic inflammatory diseases. As someone who grew up living with severe asthma, she knows what it can feel like to not know if you will be able to take your next breath. Her most recent accomplishment was supporting the development of TEZSPIRE^™ (tezepelumab-ekko), a first-in-class medicine for people living with severe asthma that is not limited to a specific type of severe asthma. TEZSPIRE is an add-on maintenance treatment for adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

We sat down with Dr. Kaur to hear about her experience living with severe asthma and how it impacted her work on TEZSPIRE and inflammation more generally.

How did living with severe asthma impact your childhood and your career as a physician scientist?

One of my biggest challenges growing up with severe asthma was not being able to play with other kids or take part in activities many other kids would do, like sports. There were days when I would have an asthma attack and have to spend the day in bed. I missed out on school days and other parts of my life because of my asthma. It made me feel like I didn’t fit in with other kids.

Because of my childhood experiences, I have always wanted to help others and become a doctor. As a physician scientist, knowing I can make an impact on people living with chronic, inflammatory diseases is very fulfilling for me.

Who had the greatest impact on your decision to pursue a career in science and medicine?

My grandmother inspired me to become a physician. She passed away from a chronic disease when I was a teenager, and I have very vivid memories of seeing her struggle. I wanted to pursue a career that could help people like her.

What does it mean to you to be able to work on potential treatments for chronic inflammatory diseases like severe asthma at Amgen?

I love what I do because I can make a difference. Inflammation affects people in so many different ways, and inflammatory diseases can have a huge impact on a patient’s day-to-day life. It’s incredibly rewarding, personally and professionally, to develop new treatments that may be able to help people live a life less defined by their disease.

TEZSPIRE was particularly exciting to me because it could potentially address an unmet need that existed for people living with severe asthma. Knowing that you can make a difference in people’s lives is inspiring. I find it very powerful and energizing and that’s what motivates me to continue working every day to support patients.

Is there a specific moment that stood out to you as you were studying TEZSPIRE?

I was excited when I saw the primary analysis data of the TEZSPIRE Phase 2b study in severe asthma. The data told us that TEZSPIRE could potentially help reduce asthma attacks for a broad population of people living with severe asthma.

What advice would you give to people who are interested in pursuing careers in science and medicine?

Careers in science and medicine require a lot of perseverance and patience, but it is incredibly fulfilling to make a difference. You can make history.

Learn more about Dr. Kaur’s journey from patient to scientist and hear from Erin, a woman living with severe asthma, about her experience in the video below:

INDICATION

TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (e.g.,rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e.,days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease

TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if TEZSPIRE will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines

The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

USE IN SPECIFIC POPULATIONS

There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see the Tezspire full Prescribing Information.

You may report side effects related to AstraZeneca products by clicking here.

How the Different Seasons Can Affect Your Asthma

Fri, 25 Feb 2022 18:54:55 Z

In this Q&A, Amgen's Dr. Andrew Lindsley describes how seasonal changes impact people living with asthma as well as how they can best protect themselves throughout the year.

Dr. Andrew Lindsley, M.D., Ph.D., is a physician scientist and board-certified pediatric Allergy and Immunology physician. He is currently the U.S. Medical Affairs Asset Lead for Amgen, working on respiratory and immunology diseases.

We sat down with Dr. Lindsley to learn more about how seasonal changes can affect people living with asthma, the most common seasonal asthma triggers and practical steps people with asthma can take to reduce their risk of an asthma flare up.

How do the different seasons impact people living with asthma?

Asthma symptoms change throughout the year due to a combination of seasonal and lifestyle factors. Fall and winter are generally the time when asthma flare ups happen most frequently. This is partially due to a rise in respiratory infections such as the common cold or flu, which spread more effectively in the large gatherings that happen during the holidays. Winter also means people are indoors more, which increases their exposure to household allergens such as dust mites and pet dander.

Spring and summer encourage more outdoor activities, which decreases household allergens but can cause people with seasonal allergies to experience flare ups. In North America, tree and grass pollens peak in mid-to-late spring and ragweed pollens peak in early fall, so those with seasonal allergies should be especially cautious of their outdoor exposure during this time.

What seasonal activities may be more prone to causing asthma flare ups?

Any activity in which air quality is reduced or compromised could cause a flare up. For indoor activities, this means being especially cautious in smoky or crowded spaces. For outdoor activities, it's important to monitor the air quality index (AQI) for your area and avoid any outdoor activities when AQI exceeds 50-100.

What does having an asthma flare up feel like when the seasons are changing?

Although there are some common symptoms such as shortness of breath, every asthma flare up is different. Some can come on quickly and suddenly, especially if the person is sick with a respiratory illness such as influenza. Other asthma flare ups can be more gradual and progressive.

People who have asthma should monitor their use of rescue inhalers and contact their doctor if they notice increasing symptoms, worsening control, or increased use of their rescue inhaler during a flare up.

What can people with asthma do to help mitigate these symptoms?

It's important to always follow the asthma management plan recommended by your healthcare provider. As recommended by your doctor, some other steps people can take include:

Get the seasonal influenza vaccine each fall as soon as it becomes available
Avoid spaces with excessive wood or tobacco smoke
Consider wearing a KN-95 or N-95 mask when in large indoor settings or traveling to help reduce exposure to viral particles as well as other asthma triggers

If your asthma is not well controlled, consider seeing an asthma specialist in your area. For help finding an asthma specialist, visit BreakTheCycle.com.

Amgen CEO Bob Bradway's 2021 Letter To Shareholders

Tue, 29 Mar 2022 17:11:14 Z

Download Amgen's 2021 Letter to Shareholders and Annual Report

Robert A. Bradway
Chairman and Chief Executive Officer

To My Fellow Shareholders:

In 2021, Amgen brought more medicines to more patients around the world than ever before. Total revenues in 2021 were up 2% from the prior year to a record $26 billion. Despite the ongoing challenges of the COVID-19 pandemic, many of our innovative medicines generated strong, volume-driven sales growth, including our cholesterol treatment Repatha^® (+26%), our osteoporosis medicines Prolia^® (+18%) and EVENITY^® (+51%), and several of our cancer therapies, such as BLINCYTO^® (+25%), Vectibix^® (+8%), and KYPROLIS^® (+4%). Sales of our high-quality biosimilars—which provide cost-effective treatment options for healthcare systems globally—exceeded $2 billion collectively, led by MVASI^® (a biosimilar to Avastin^®¹, +46%) and AMGEVITA^™ (a biosimilar to HUMIRA^®², +33%). Product sales outside the U.S. grew 12% to $7 billion, with particularly strong growth coming from the Asia-Pacific region (+36%).

We achieved record non-GAAP earnings per share in 2021 of $17.10,³ up 6% from the prior year, and free cash flow of $8.4 billion.³ Amgen's non-GAAP operating margin for the year was 51.1%,^3,4 up slightly from 2020 and among the highest in the industry, driven by ongoing productivity efforts we have embedded throughout our business.

Total shareholder return was 1% in 2021 and has increased by nearly 350% over the past ten years. We returned $9 billion to shareholders in 2021 through dividends and share repurchases.

We invested $4.8 billion⁵ in research and development in 2021, up 15% from the prior year, advancing numerous potential new medicines at all stages in our pipeline and securing three significant regulatory approvals:

LUMAKRAS^®/LUMYKRAS^® is the first and only medicine approved for the treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC), the culmination of a 40-year quest to treat cancers with this particular mutation. First approved in the U.S. in May 2021, LUMAKRAS has now been approved in nearly 40 countries around the world. We continue to study it as both a monotherapy and in combination-therapy regimens for NSCLC and other solid tumors, including colorectal and pancreatic cancer.
TEZSPIRE^™ was approved in the U.S. in December 2021 as the first and only biologic for severe asthma that does not have a phenotype or biomarker limitation within its approved label. This gives us the opportunity to reach a broad population of patients who are living with this serious disease and are potential candidates for a biologic therapy like TEZSPIRE. We are also studying TEZSPIRE in several other indications, including chronic rhinosinusitis with nasal polyps and chronic obstructive pulmonary disease.
Also in December, Otezla^® was approved for an expanded indication in the U.S., making it the first and only oral therapy approved to treat plaque psoriasis across all levels of severity and enabling us to reach an additional 1.5 million patients. We expect Otezla—which generated $2.2 billion in 2021 sales globally—to be a strong contributor to Amgen's growth over the next several years.

$0B

2021 Total Revenues

Non-GAAP
Earnings Per Share³

$0B

Research and Development Investment

Non-GAAP
Operating Margin^3,4

We completed several important business development transactions in 2021, adding two promising new medicines to our late-stage pipeline and strengthening our discovery research capabilities. I will discuss these in more detail later in this letter.

All in all, it was another year of strong execution, in which Amgen delivered in the here and now while setting up for continued success in the years ahead.

SERVING MORE PATIENTS, DELIVERING STRONG GROWTH

Looking to the future, this is an exciting time to be in biotechnology—a moment when the need for innovative medicines and our ability to innovate are both expanding dramatically.

The need for innovative medicines is driven by a rapidly aging global population. There are already 700 million people worldwide over the age of 65, and another 150 million people will turn 65 by the end of the decade. Those over 65 tend to consume three times as much healthcare as younger people do as they wrestle with diseases of the aging process, such as cardiovascular disease, osteoporosis, and cancer.

Laonis Quinn

Nick Hagen/Getty Images for Amgen

How One Patient Is Expanding Asthma Awareness

The U.S. approval of Amgen's TEZSPIRE^™ in late 2021 gives people living with severe asthma a compelling new treatment option. Laonis Quinn—a registered nurse, a certified asthma educator, and an asthmatic herself—has dedicated her life to expanding awareness and understanding of severe asthma, especially within the Black community where the disease is particularly prevalent. Through the Breathe: Anthony J. Chapman Asthma Foundation, founded in honor of her late son, Laonis works to provide asthma management training to schools, churches, and youth organizations in Detroit, where she lives.

"There are thousands of people who have stories like I do," Laonis observes. "We are the faces behind severe asthma. I'm grateful to Amgen for its commitment to scientific research, and I appreciate the company's efforts to help people with this disease to live healthier lives."

Amgen values the perspectives of people such as Laonis who suffer from diseases that our medicines are intended to treat. By understanding their individual journeys, we can improve our ability to serve patients.

The ability to innovate is driven by remarkable advances in science and technology. To give just one example, in 2012 Amgen acquired deCODE Genetics, which at that time had accumulated detailed genetic information on approximately 100,000 people, all from deCODE's home country of Iceland. Today, through a number of collaborations, we have this information for 2.5 million volunteers worldwide, as massive gains in technology have markedly lowered the time and cost required to gather this data.

While our industry is not without its challenges, we believe the fundamentals remain very attractive for those companies that can innovate consistently and at speed. We expect to be one of those companies.

Our confidence is reflected in the long-term financial guidance we provided to the investment community in February of this year. In short, we believe we can deliver attractive annual revenue and non-GAAP earnings per share growth, on average, through the end of the decade, based on the assets we have in-house. Any growth from future business development activity would be additive to this organic outlook. Here is how we will do it:

Growing Our Innovative Medicines Already on the Market

COVID-19 has understandably overshadowed all other health concerns over the past two years. But eventually the pandemic will recede and, when it does, society will need to confront a number of other very serious health challenges that have not gone away—and where Amgen has compelling solutions to offer. Our medicines already reach roughly 10 million patients around the world, but we know the needs are much greater than that. I will highlight three therapeutic areas where this is especially true:

Cardiovascular disease is responsible for one out of every three deaths globally—85% of which are due to heart attacks and strokes. With Repatha, we have an innovative medicine that significantly lowers LDL cholesterol, which is the leading modifiable risk factor for these two life-altering events. Repatha has reached roughly 1 million patients worldwide since its launch in 2015, but that's just a fraction of the estimated 24 million patients worldwide with atherosclerotic cardiovascular disease who are at high risk for a heart attack or stroke. Sales of Repatha were $1.1 billion in 2021, and we believe it will be a multi-billion-dollar product for us, growing steadily through 2030.
An estimated 200 million people worldwide suffer from osteoporosis, resulting in an osteoporosis-related fracture every three seconds. With Prolia and EVENITY, we have a powerful one-two punch to significantly reduce the risk of fracture in the millions of high-risk patients who are not yet receiving treatment. These two medicines generated a combined $3.8 billion in sales in 2021. We expect Prolia to continue to grow through its loss of exclusivity in the U.S., with EVENITY sales growing through the end of the decade.
Despite great advances, cancer still claims more than 10 million lives a year, and five-year survival rates across all cancers remain below 70%. We have several medicines available to patients that can make a meaningful difference in the fight against cancer including LUMAKRAS, mentioned above, and KYPROLIS, which, in combination with two other therapies, has been shown to significantly enhance progression-free survival rates in patients with relapsed or refractory multiple myeloma. I will also highlight important data—published in The Journal of the American Medical Association (JAMA) in 2021—supporting BLINCYTO as an effective treatment for children with relapsed acute lymphoblastic leukemia, the most common form of pediatric cancer.

You can find more information about all our products at www.amgen.com/products.

Advancing New Medicines Through Our Pipeline

As we work to bring Amgen medicines already on the market to more patients, we also are advancing a number of promising new treatments through our pipeline that offer significant opportunities for additional growth. Some of these medicines were discovered internally, while others have come to us through acquisitions and alliances—a balance that has served us well as we seek the best innovation available, regardless of origin. I will highlight five first-in-class programs, all currently in either phase 2 or phase 3 clinical trials:

Bemarituzamab is being studied in patients with gastric cancer, which is the fifth-most-common cause of cancer death worldwide and particularly prevalent in the Asia-Pacific region. Data from a phase 2b trial showed a meaningful improvement in median overall survival when bemarituzumab was added to chemotherapy. This molecule came to us through our 2021 acquisition of Five Prime Therapeutics, and we are also investigating its potential in other cancers, including squamous non-small cell lung cancer.
Tarlatamab is being studied in patients with relapsed/refractory small-cell lung cancer, a particularly aggressive form of cancer where neither survival rates nor treatment options have changed much in several decades. In a phase 1 trial, tarlatamab demonstrated significant evidence of antitumor activity, with a preliminary median duration of response in excess of one year—an exceptional result in patients who often have only a few months to live. We believe this molecule also has potential as a treatment for neuroendocrine prostate cancer.
AMG 451 is being studied in patients with atopic dermatitis (commonly known as eczema) in collaboration with our long-time partner Kyowa Kirin, another transaction we completed in 2021. Atopic dermatitis affects more than 30 million people around the world, and new treatment options are very much needed. Data from a phase 2b study of AMG 451 showed substantial improvement in patients as measured by the Eczema Area and Severity Index, as well as a prolonged duration of response that may allow for less-frequent dosing.
Efavaleukin alfa is being studied in patients with two serious autoimmune diseases, systemic lupus erythematosus and ulcerative colitis. This molecule has been shown in a phase 1 trial to increase the number of T regulatory cells, which act as a natural brake on the immune system when it goes out of balance, as occurs in many patients with these diseases.
Olpasiran is being studied in patients with high levels of lipoprotein(a), a type of "bad" cholesterol that affects 20% of the world's population. Unlike LDL cholesterol, lipoprotein(a) levels are genetically determined and cannot be modified by diet or exercise. Early data show that a single dose of olpasiran leads to profound reductions in lipoprotein(a) and that this reduction is durable, suggesting that the dosing interval can be relatively infrequent.

You can find more information about our pipeline at www.amgenpipeline.com.

Expanding Our Biosimilars Portfolio

About ten years ago, recognizing an emerging opportunity, we set out to build a world-leading biosimilars portfolio—and we've done that. Today, we offer five biosimilars around the world, expanding access to high-quality biologics for patients, while also delivering cost savings to healthcare systems.

As noted above, AMGEVITA is a biosimilar to HUMIRA, the world's best-selling drug. We've launched AMGEVITA in more than 50 markets around the world and look forward to bringing it to the U.S. next January. We then expect over the following several years to launch biosimilars to SOLIRIS^®⁶, STELARA^®⁷, and EYLEA^®⁸—products that collectively generated roughly $17 billion in 2021 sales—with still more launches planned after that. All told, we expect to double our 2021 biosimilars sales by the end of the decade.

Deepening Our Global Presence

For many years, the bulk of Amgen's sales came from a single market, the U.S. Today, our products are available in approximately 100 countries, and we expect sales outside the U.S. to account for roughly 35% of our total sales by 2030, up from less than 25% ten years ago. We are especially excited by our growth prospects in the Asia-Pacific region, where China and Japan rank as the world's second- and third-largest pharmaceutical markets, respectively.

We took full ownership of our business in Japan in 2020, and our portfolio of products—such as EVENITY, which launched in Japan first among all markets—is particularly well suited to address the needs of a country where nearly 30% of the population is 65 and over. In China, which has more people over 65 than any country in the world, we continue to grow our business through products such as Repatha and Prolia. Our combined sales in these two markets rose nearly 70% in 2021.

Kazuo Hasegawa

Japan Makes It Nearly Forty Countries for LUMAKRAS

In early 2022, Japan's Ministry of Health, Labour and Welfare approved LUMAKRAS, marking a paradigm shift in the treatment of patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC).

"Treatment options for these patients are extremely limited," says Kazuo Hasegawa, a lung cancer survivor and one of the country's leading patient advocates. "We are encouraged to see Amgen's efforts to bring an innovative new medicine for this disease to patients in Japan."

Thousands of patients around the world have already received LUMAKRAS, and Amgen is progressing the largest and broadest global KRAS G12C inhibitor development program with unparalleled speed.

RECONCEIVING DRUG DISCOVERY

Biopharmaceutical research and development is one of the most challenging pursuits in business. Now, however, the rapid convergence of "biotech" and "tech" is fundamentally redefining how we go about this work, especially in the area of early research.

I already mentioned our expertise in human data. We now have more than 100 petabytes of human data—that's 10¹² bytes of genetic information—and that number is growing every day. These data yield powerful insights into biology and disease that inform virtually all of our programs entering clinical development, increasing their chances of success.

We have also been investing heavily in the emerging field of multispecific medicines, which give us the potential to tackle the 85% of disease-causing targets in the body that have long been considered "undruggable." Multispecifics generally work in one of two ways—either by using a built-in "address label" to concentrate their impact where it is most needed, or by acting as "molecular matchmakers" to link a disease-causing target to a potent natural effector in our bodies that acts upon that target.

Multispecific drugs currently comprise approximately 60% of Amgen's preclinical pipeline, and we believe they have the potential to revolutionize our industry in much the same way biologics did 40 years ago. Our acquisitions of Nuevolution in 2019 and Teneobio last year significantly enhanced our multispecific capabilities in small and large molecules, respectively—and three transactions we announced at the start of this year, with Generate Biomedicines, Arrakis Therapeutics, and Plexium, strengthen our capabilities further still.

We are also harnessing the power of artificial intelligence and machine learning to improve how we discover and develop biologic medicines. In the past, we have built these medicines using proteins that naturally occur in the human body, relying on iterative, multi-year cycles in which we engineer and test prototype after prototype before moving into clinical trials. Even then, despite our best efforts, these protein-based medicines often behaved unpredictably, failing to generate the desired effect.

Today, thanks to remarkable technological advances that have fundamentally changed our understanding of proteins, we no longer need to rely solely on Mother Nature, but can instead begin to work on building proteins from scratch with confidence that they will predictably perform a desired function. It's early days, but where we have deployed these new technological insights, we have reduced our discovery timelines by half while doubling our success rates—very exciting progress that is enabling us to move at what we call the "speed of tomorrow."

Rutendo Kahari

Everyone Needs Science, and Science Needs Everyone

One of the signature programs supported by the Amgen Foundation is LabXchange, a free, online science education platform created by Harvard University and launched in 2020. LabXchange provides the opportunity for students, teachers, and lifelong learners of all ages to practice scientific experiments using interactive simulations of the same cutting-edge equipment found in modern biotech laboratories. More than 16 million people have utilized LabXchange to date, with the platform proving especially valuable as schools moved to virtual learning during the COVID-19 pandemic.

"LabXchange helped me to sharpen my skills at a time when access to my physical lab at school was cut short due to constant COVID-19 lockdowns," says Rutendo Kahari, a student and aspiring researcher from Zimbabwe.

SUPPORTING OUR PEOPLE

My optimism for Amgen's future ultimately stems from my belief in Amgen's people. We regularly survey our employees and know they are passionate about Amgen's mission to serve patients and understand the role they play in advancing that mission. They have performed exceptionally well under very challenging circumstances over the past two years of the pandemic. Thanks to their hard work, we have in hand what we need to succeed through the end of the decade and beyond. Our job now is to execute—and our people are exceptional at doing just that.

Much has been written about the "Great Resignation," as the pandemic has prompted many people to reassess their lives and careers. We are working hard to make sure that Amgen continues to be an attractive employer—to those already with us and to those considering new opportunities. We offer the chance to do meaningful work in an increasingly diverse, inclusive environment. We have adopted a more flexible approach to office-based work, enabling our people to do their jobs where and when it works best for them. We emphasize career development, with more than 2,700 employees earning promotions in 2021. We have increased the mental health resources we provide, which is vitally important given the stress and strain of the current moment, particularly on parents and people of color. And we are increasingly using technology to automate or simplify many low-value tasks, freeing up our people to focus on the most important and satisfying work.

We take nothing for granted, but we are pleased with how we are doing. Our attrition rate is up only slightly from prepandemic levels and is generally lower than our industry peers. We see an acceptance rate of greater than 90% on the job offers we extend and are filling open roles at the same pace we filled them prior to the pandemic. We have earned numerous recognitions as a great place to work, including being named one of "America's Best Large Employers" by Forbes magazine, as well as one of the "World's 25 Best Workplaces^™" by Fortune and Great Place to Work^®.

Moya Watts

Sharpening the Focus on Mental Health

In order to advance our mission to serve patients, Amgen is committed to giving our employees the resources they need to take care of themselves. In addition to traditional benefits focused on physical health, this includes an increased emphasis on mental health, given the uncertain and, at times, unsettling world we live in.

Moya Watts, who works at the Amgen Capability Center in Tampa, Florida, took advantage of these benefits last year when she began experiencing signs of burnout. "The Wellness Program manager for our site helped me establish a routine to make my mental health a priority," she says. "Amgen has been amazing during these past few years, and I really appreciate the programs and support they've provided."

As a member of the Amgen Black Employee Network, Moya was also recently given the opportunity to help select non-profit organizations in the Tampa community that would receive grants from the Amgen Foundation to advance social justice.

"To be part of the committee that picked these organizations is more than I could've asked for," Moya says. "It makes me proud and brings me peace of mind to work for a company like Amgen that is making a real difference."

OPERATING RESPONSIBLY

Our people also want to work for a company that does more than just earn a profit—and we offer that, too. We are fortunate that our core business of improving human health, in and of itself, contributes meaningfully to the greater good. But society confronts many challenges these days, and we are working to do our part to address them. Indeed, Amgen has been a responsible corporate citizen long before stakeholders came to expect that of businesses. I will share a few examples:

More than 30 years ago, we created the Amgen Foundation⁹ to inspire the next generation of innovators. Today, the foundation provides free, world-class science education programs that reach millions of students worldwide every year.
More than 20 years ago, we created the Amgen Safety Net Foundation⁹ to help patients in financial need gain access to our medicines, providing $6 billion¹⁰ worth of our medicines at no cost in just the past five years.
Also more than 20 years ago, the first employee resource group was formed at Amgen, bringing together Black colleagues at our headquarters in Thousand Oaks, California. Today, more than 11,000 Amgen staff around the world participate in nearly a dozen employee resource groups—each of which is sponsored by one of my direct reports.
Fifteen years ago, Amgen began implementing a series of projects to reduce our impact on the environment, resulting in a 33% reduction in carbon emissions, a 30% reduction in water used, and a 28% reduction in waste, even as our business expanded.¹¹ Now, we're aiming even higher, with plans to achieve carbon neutrality in our operations by 2027, along with additional reductions in water used and waste disposed of 40% and 75%, respectively.¹²

You can learn more about our commitment to good corporate citizenship by reading our latest Environmental, Social, and Governance Report at www.amgen.com/responsibility.

Sandra Rodríguez-Toledo

Kirk Irwin/Getty Images for Amgen

New and "Greener" Biomanufacturing in Central Ohio

In November 2021, Amgen marked a significant expansion of its U.S.-based manufacturing footprint by breaking ground on a new, state-of-the-art facility near Columbus, Ohio. We expect to employ approximately 400 people at this facility who will assemble and package our medicines for the U.S. market. "Amgen Ohio" will be led by Sandra Rodríguez-Toledo, who joined the company in 2013 and previously held roles of increasing responsibility at our largest manufacturing site, in Juncos, Puerto Rico.

"I'm honored to lead this new facility and help to have it up and running in 2024," Sandra says. "We look forward to doing our part in Ohio to continue Amgen's proud tradition of serving every patient, every time."

Sandra notes that Amgen's decision to locate its new plant in Ohio was driven, in part, by access to diverse talent. Amgen is a founding member of OneTen, a coalition of large companies that collectively aim to hire 1 million Black Americans into well-paying jobs over the next 10 years, with a particular focus on those without four-year college degrees.

"As a woman working in a traditionally male-dominated field," she says, "I am deeply committed to having the most diverse workforce possible at our new plant."

Sandra says that Amgen Ohio will also be built to exacting environmental standards, consistent with the company's goal of achieving carbon neutrality in its operations by 2027.¹²

Amgen announced plans in 2021 to build a second new manufacturing facility, this one in the Raleigh-Durham area of North Carolina. Together, the new plants in Ohio and North Carolina represent a capital investment of $1 billion by Amgen in the U.S.

Brent Meeks

Amgen Plugs In

In 2021, Amgen launched a pilot program adding more than 100 electric vehicles to the company's fleet of cars. Over time, we expect to have at least 1,800 electric vehicles on the road around the world—helping us to meet our commitment to achieve carbon neutrality by 2027¹². Brent Meeks, a senior specialty sales representative in Northern California, was among the first volunteers for the pilot program. "I was excited to join the program because I know electric vehicles are the future," Brent says. "Along with the sustainability benefits, they're fun to drive!"

MAINTAINING LEADERSHIP

Of the thousands of companies founded during the biotech revolution of the 1980s, only two of note remain independent to this day. One of them is Amgen, and that's not by chance. We wake up every morning knowing that, in our business, we innovate—or we disappear. We have had great people delivering great innovation throughout our history. I am convinced we have the right people focused on the right things for Amgen to remain a leader through the end of this decade and beyond.

On behalf of Amgen's board of directors, our senior leadership team, and our employees around the world, I thank you for your continued support of our company and the important work we do.

Robert A. Bradway
Chairman and Chief Executive Officer
March 18, 2022

Avastin is a registered trademark of Genentech, Inc.
Humira is a registered trademark of AbbVie, Inc.
This is a non-GAAP financial measure. See reconciliation to U.S. generally accepted accounting principles (GAAP) accompanying this letter.
Non-GAAP operating margin is calculated as a percentage of product sales.
Includes upfront payment for Kyowa Kirin Co. Ltd. collaboration discussed below.
SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.
STELARA is a registered trademark of Janssen Biotech, Inc.
EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc.
The Amgen Foundation, Inc. and the Amgen Safety Net Foundation are separate legal entities entirely funded by Amgen.
Valued at wholesale acquisition cost.
Reductions take into account only verified reduction projections, and do not take into account changes associated with the contraction or expansion of the Company and are measured against a 2007 baseline.
Carbon neutrality goal refers to Scope 1 and 2 emissions.

Message from Amgen CEO Bob Bradway on Ukraine and Amgen Foundation Grant

Thu, 03 Mar 2022 21:53:26 Z

On March 3, 2022, Amgen CEO Bob Bradway sent the below message to employees globally expressing sadness over events unfolding in Ukraine and outlining how the Amgen Foundation will offer support to the Ukrainian people through a pair of disaster relief grants, and through a program to match donations made by Amgen staff to select charities.

We are saddened by the events unfolding in Ukraine. While we do not have staff in Ukraine, as a global organization, we have many staff of Ukrainian and Russian nationality or descent as well as business activity in both countries. We are actively monitoring this situation with our priority being the safety of our staff and the patients in the region who rely on our medicines.

To assist the Ukrainian people, the Amgen Foundation has approved two disaster relief grants of $250,000 each to International Medical Corps and Project Hope.

We have also opened the Amgen Foundation Disaster Relief Matching Gifts Program, allowing all staff globally to receive the Foundation match when they donate to select charities to support humanitarian efforts related to the conflict in Ukraine.

We are a mission- and values-based company. This perspective transcends borders. We have supported one another and stayed focused on serving patients throughout the pandemic, and I ask that we continue to do so again now.

Thank you, as always, for the important work you do every day.

Best Regards,

Bob Bradway
Amgen CEO

Providing Healing, Promoting Hope: Women’s History Month 2022

Wed, 23 Mar 2022 16:15:59 Z

At Amgen, investing in women is a critical pathway for future generations and for the patients we serve. Women’s History month is a celebration of women’s contributions to history and progress. The national theme this year is “Providing Healing, Promoting Hope,” leading us to recognize the world’s healers and hope-givers—as well as our own patient-focused women.

Read more about the women of Amgen and their stories. Leaders like our Chief Human Resources Officer, Lori Johnston, who shared her personal journey with migraine. Scientists like Joanne Dai, whose research is focused on helping patients with cancer. Innovators like Jane Parnes who leads the early development of therapeutic candidates for diseases of the inflammatory and cardiometabolic systems. Mentors that are committed to developing fellow women at Amgen. And many, many more.

Innovation² with Jane Parnes and Nina Tandon

Innovation² is a video series created by Amgen in collaboration with The Nation of Artists to highlight how some of the brightest minds think about innovation.

Why Do Up-and-Coming Scientists Join Amgen's Postdoc Program?

Ahead of Amgen's 5th annual Postdoctoral Fellows Conference, three postdocs say it's all about cutting-edge research and valuable experience in biotech.

Candid Conversations: Women Empowered to be Exceptional (WE2)

In celebration of Women’s History Month, this video features a transparent dialogue between Murdo Gordon, executive vice president, Global Commercial Operations, executive sponsor of Women Empowered to be Exceptional (WE2) and Nada Obeid, executive director, U.S. Value & Access, global chair of WE2.

Margaret Chu-Moyer Honored with Prestigious Portoghese Lectureship

Margaret, a VP of Research at Amgen, is the second woman and the second chemist based in industry to be honored by the American Chemical Society and the Journal of Medicinal Chemistry.

Amgen's Head of Human Resources Lori Johnston Gets Personal About Her Migraine Journey During National Migraine and Headache Awareness Month

Lori Johnston, Executive Vice President, Human Resources at Amgen, shares her migraine journey and discusses how HR professionals can support people living with migraine.

Tackling Adversity Through Diversity

Through the challenges of the pandemic, these leaders—and recent Healthcare Businesswomen’s Association winners—helped ensure that clinical trials and biosimilars development continued.

Mentoring Women: Amgen's Commitment to Developing Diverse Leaders

Since its inception in 2016, Amgen’s Women Empowered to be Exceptional (WE2) group mentoring program has invested in over 1,000 staff, helping them develop personal networks and grow their business acumen. Find out more about how it works, why it matters and where they are expanding.

4 Ways Amgen Is Working With Organizations to Improve Osteoporosis Care and Bone Health

Amgen remains committed to predicting and helping prevent the impact of serious diseases like osteoporosis.

Three Amgen Leaders Recognized for Advancing Gender Equity

Thu, 24 Mar 2022 18:27:30 Z

For Amgen’s Healthcare Businesswomen Association (HBA) award winners, mentorship, empowerment, and DI&B rise to the top.

When Rohini Deshpande first started at Amgen in 1997, on the heels of her postdoctoral work at the University of Michigan and UCLA, she found a laboratory environment where cutting-edge science was the priority. Both men and women actively collaborated to solve a key challenge of the day—turning monoclonal antibodies into a new therapeutic modality for Amgen.

“I questioned whether I was ready or good enough to take a job at Amgen, but the science I had done before fit in very well with Amgen’s new goals,” says Deshpande. "Certainly, there were fewer women in biotechnology —and in STEM [science, technology, engineering and math] fields generally—then, but I felt very supported by male and female mentors and role models who helped guide and inspire me.”

It turns out that not only was Deshpande good enough to do her first job at Amgen—but also many others that followed with increasing levels of responsibility. She now serves as Amgen's vice president of Drug Substance Technologies and the site head for the Amgen Massachusetts facility.

Deshpande thrived in Amgen’s labs, and 25 years later, she’s not only one of the company’s highly regarded scientists, but also a role model and mentor herself, who was recently recognized by the Healthcare Businesswoman’s Association (HBA) as a Luminary award recipient for 2022.

Deshpande is one of three Amgen leaders recognized by HBA this year. Susie Tappouni, vice president, Corporate Affairs, also received the Luminary award, and Disha Patel, director, Digital Technology and Innovation, was named a Rising Star.

“I first joined HBA in the late 2000s, after learning about research they had done on some of the reasons women in the healthcare industry were either dropping out of the workforce or not advancing past middle management,” Tappouni says. “That’s when I became motivated to truly advocate on behalf of myself and other women around me whenever I could.”

Actively empowering women at Amgen

All three recipients come from different parts of the healthcare industry, from communications to scientific research to information systems and technology, but one thing they all have in common is their active roles in Women Empowered to Be Exceptional (WE2), an employee resource group with chapters at Amgen sites around the world.

“WE2 has become an epicenter of powerful discourse on the challenges we’re facing as women in leadership, or aspiring to leadership,” Tappouni says. “The organization creates meaningful forums to address the intersection of inequality in gender and race in the workplace, and it has become an effective resource for building a productive network.”

As the sponsor of WE2 for the Amgen Massachusetts site, Deshpande leads group mentoring sessions for women across a variety of functions. “I really enjoy having inclusive conversations about the common challenges women experience in workplaces,” she says. “For many women, including myself, a common change when taking a leadership role is getting comfortable being in the spotlight, so we talk a lot about the importance of standing up and speaking out. In science we like to say that data speak for themselves, but as leaders we must stand up and speak for the data—and our teams.”

Susan Burke, a director of Process Development at Amgen Massachusetts site says she appreciates the opportunities for open communication that Desphande’s group mentoring sessions provide. “Hearing the candid perspective of a female executive leader talking about the skills and strategies women need to develop as they advance in their careers has greatly enriched the program and helped me gain a deeper understanding of the professional and corporate culture at Amgen,” she says.

Patel currently serves as the global vice chair for WE2, a mentor for the group at Amgen’s headquarters in Thousand Oaks, Calif., and she’s also working to create the WE2 community at Amgen Ohio in her new role as Digital Technology and Innovation site lead. “I am a firm believer in servant leadership and paying it forward,” she says. “The opportunity to be engaged with this group early on and see how it has evolved into a durable capability within our organization to help support, encourage, develop and advance women is wonderful.”

Mentorship makes a difference

The HBA is an organization created around the core purpose of furthering advancement and impact of women in the business of healthcare through the guidance and support of mentors and sponsors. “Earlier in my career, I identified more senior women who had knowledge and experience of what to look out for as I began my journey. One of my most impactful, amazing mentors in that early phase career was Diana McKenzie, Amgen’s previous chief information officer,” Patel says. “As I got a few more years under my belt, I started to look for mentors that had different experiences or skill sets that I admired, regardless of tenure, as this brought on different ways to look at my career.”

Tappouni explains that she found one of her most impactful mentors after transitioning from consulting to her first “in-house” job, leading science communications for the American Society of Clinical Oncology (ASCO). “Kristin Ludwig (until recently, the chief marketing and communications officer for ASCO) was a champion of mine when I worked there and has remained a mentor to this day,” Tappouni says. “I really admired the way she led her team through her no-nonsense style, how she was so supportive of the empowerment of her people, embracing of inclusiveness and belonging, and her open-mindedness to always listen, evolve and innovate.”

For Deshpande, it was the leaders she reported to along her journey that she credits with helping shape her career. “They pushed me out of my comfort zone and believed in me – even more than I believed in myself,” she says. “I trusted their confidence, became an avid learner and it ended up being a fantastic experience.”

Growing Amgen’s focus on Diversity, Inclusion and Belonging

Deshpande says that Amgen’s culture has been professional and equitable throughout her time here, and that she especially appreciates the company’s clear, strong and renewed commitment to Diversity, Inclusion and Belonging (DI&B) in recent years.

“I see Esteban Santos (executive vice president of Operations) so committed to diversity, and I realize that we are making it a purposeful, sustainable journey toward an inclusive future,” she says. “It feels very gratifying to be part of a team where we discuss DI&B openly, celebrate our progress, and evaluate areas needing more work.”

Throughout her more than 16-year tenure with Amgen, Patel has taken an active role in Amgen’s DI&B efforts through a variety of internal and external programs. “I have a front row seat to seeing and influencing how we are developing and promoting women, and women of color, within the company,” she says. “I am encouraged in our journey as a whole for Amgen in DI&B, and over the past few years our ability to actively discuss topics like unconscious bias, psychological safety, and what it means to be an ally, not to mention the number of career promotions and lateral moves that are occurring, it’s a step in the right direction.”

“Amgen has made significant strides on the DI&B front in the past few years,” Tappouni adds. “But we can’t let up on our efforts to continue recruiting talented and diverse women into Amgen from all corners of the world and at all levels. We need to redouble our efforts to tap into new tributaries for talent and create productive new networks to draw in the future women leaders of tomorrow.”

Amgen has been a corporate partner of HBA since 2010, supporting the organization’s dedication to furthering the advancement and impact of women in the business of healthcare. Members of Amgen’s senior leadership nominate and review the Rising Stars and Luminaries who exemplify leadership and have contributed significantly to the company’s business.

Amgen Breaks Ground on New Drug Substance Manufacturing Facility in North Carolina

Wed, 23 Mar 2022 23:35:43 Z

Amgen successfully broke ground on its new biomanufacturing facility in Holly Springs, N.C., marking another important step in the company's plans to invest nearly $1 billion into new manufacturing capacity across the U.S. The event took place on March 7, and it was attended by Amgen CEO Bob Bradway and Amgen North Carolina site head Bob Kenyon, along with N.C. state governor Roy Cooper, U.S. senator from N.C. Thom Tillis, N.C. secretary of commerce Machelle Baker Sanders, and Holly Springs mayor Sean Mayefskie.

“We chose Holly Springs over more than a dozen other potential locations for this new plant because the Raleigh-Durham area offers advantages that no other region could beat: an attractive and welcoming business climate, a growing reputation for life science innovation, a diverse pool of talent, and a convenient location that fits well into Amgen’s overall manufacturing and distribution network,” Bob Bradway said in his remarks at the event.

Amgen plans to invest $550 million into building the new drug substance manufacturing facility in Holly Springs, bringing around 355 skilled, well-paying jobs to the area, which is a preferred and fast-growing hub for the life sciences and biotech industries. Amgen also recently broke ground on a new packaging and assembly plant in New Albany, Ohio, and between the two facilities, will invest more than $1 billion in U.S. manufacturing. Amgen’s current U.S. manufacturing footprint includes facilities in Juncos, Puerto Rico; Thousand Oaks, Calif.; and West Greenwich, R.I.

“This area—and North Carolina in general—attracted us due to the access to great and diverse talent, and we intend to take advantage of that as we build our team,” said Bob Kenyon. “The culture at this site will be one of diversity, inclusion and belonging where every single person can feel comfortable in the workplace.”

Constuction of the Amgen North Carolina facility will help support the growing demand for Amgen medicines in the U.S. The site will use traditional drug substance technologies and Amgen’s latest innovations to create a hybrid facility, called FleXBatch. This makes drug substance manufacturing more efficient and will help Amgen achieve its company-wide sustainability goals of reducing water use by 40%, cutting waste disposal by 75% and becoming carbon neutral by the year 2027.

“This new FleXBatch plant exemplifies Amgen’s approach to innovative and sustainable biomanufacturing, which – I’m pleased to announce – we are now calling Amgen Ecovation,” Bob Bradway said. “This new name underscores what is today and has always been distinctive about biomanufacturing at Amgen: It is highly innovative, efficient, safe, and environmentally sustainable – all in the service of benefiting patients with medicines manufactured according to the highest quality standards.”

Construction of Amgen North Carolina began at the end of 2021, and manufacturing operations are expected to start in 2025, with licensure anticipated the following year.

Increasing Communication and Collaboration Among Cancer Care Teams to Improve Biomarker Testing in NSCLC

Wed, 09 Mar 2022 22:30:24 Z

Comprehensive biomarker testing can play an important role in the personalized treatment for patients with non-small cell lung cancer (NSCLC). Research has shown that people living with NSCLC who undergo biomarker testing and receive genotype-directed targeted therapy have a 31% reduced risk of death and an improved survival duration compared to patients with an identified oncogenic mutation who did not receive targeted therapy.¹ This is why it's vital to increase accessibility to testing and why Amgen is working with the broader healthcare community to demystify the process and help everyone – from oncologists and nursing staff to the electronic medical record managers and administrative team – to have the information and tools to successfully implement biomarker testing for their patients.

Cancer care teams can face several challenges regarding biomarker testing in the clinical setting. From cost, to inadequate tissue sampling, turnaround time, and communication challenges among care staff and patients – these barriers can impede healthcare providers' ability to treat patients with personalized care.

In a recent event with the Association of Community Cancer Centers (ACCC), I-Fen Chang, vice president, Global Medical Oncology at Amgen, moderated a panel with oncology experts, focusing on the hurdles cancer care teams face when it comes to implementing biomarker testing for patients and what can be done to ease these burdens.

"One of the most stressful times for patients is when they've been told they have cancer and the turnaround time for [biomarker] testing can be much longer than a patient can stand and sometimes much longer than a physician can stand," said Dr. Gerard Silvestri, Professor of Thoracic Oncology, Medical University of South Carolina. "There is sometimes a real lack of clear communication between the pulmonologist, pathologist and oncologist treating the patient. Having that triad of physicians meet and talk about when they're going to test, who they're going to test, how they're going to prepare the specimen, who they're going to send it to, and how they're going to manage the results of that is critically important."

To help overcome some of these barriers and work towards needed solutions, the Association of Community Cancer Centers has created a roadmap outlining simple steps cancer center staff can take towards successful and sustained biomarker testing implementation. Increasing accessibility to testing will give patients and their care team helpful guidance when deciding what treatment might be right for them. For more detail information on specific steps, please see the full roadmap from the Association of Community Cancer Centers here. The content references are provided by an independent, non-profit organization that may provide useful information and resources. Amgen has no control over these programs and provides information as a courtesy only.

And if you or a loved one is interested in learning more about the benefits of biomarker testing, click here. Amgen also provides a suite of educational resources on biomarker testing for HCPs and patients. Be sure to check out the latest video presented by Dr. Harry Hwang that discusses the most common barriers to biomarker testing and how to overcome them.

References:

Kris MG, et al. JAMA. 2014;311:1998-2006.

5 Things Amgen is Doing to Help Bend the Curve in Cardiovascular Disease

Fri, 08 Apr 2022 00:51:06 Z

Every year the American College of Cardiology annual meeting brings together leaders from across the cardiovascular community to learn about the latest academic research in cardiovascular health. But despite great advances in recent years, cardiovascular disease remains a leading public health challenge globally.¹ Amgen has maintained an ongoing commitment to helping people with cardiovascular disease. But no company can do it alone. It takes coordinated efforts in patient education, healthcare access and public health, along with continued biomedical innovation, to address unmet needs in preventing subsequent cardiovascular events and treating cardiovascular disease.

Here are 5 things that Amgen is doing to help people with cardiovascular disease:

1. Decoding human biology to unlock new treatments

Sometimes genetic insights lead to the development of a new target or new therapy in a remarkably short time frame, as was the case with Amgen’s development of Repatha^® (evolocumab), the first PCSK9i inhibitor approved to reduce cardiovascular events like heart attack and stroke in patients with cardiovascular disease, and monoclonal antibodies that have now been used to treat more than 1 million patients.^2,3 Through its work with deCODE, about 65% of Amgen’s non-oncology portfolio has been genetically validated to various degrees.⁴

2. Addressing cardiovascular disease in places with the highest unmet needs¹

To increase understanding of this globally important issue, in 2019, Amgen and the CDC Foundation partnered on a five-year, global cardiovascular health initiative to expand the evidence base for cardiovascular disease risk factors, with a focus on low- and middle-income countries. Through this collaboration, Amgen supports the collection and analysis of data to improve understanding of the causes of cardiovascular disease and interventions that may improve patient outcomes.

3. Designing research for the real world

While randomized clinical trials (RCTs) are the “gold standard” for evaluating the safety and efficacy of new therapeutic agents, strict inclusion and exclusion criteria mean that trial populations are often not representative of the patient populations encountered by clinical practices.⁵ Patients with cardiovascular disease often have comorbidities and socio-economic factors that impact treatment outcomes.^6,1 That’s why Amgen is investing in studies to evaluate treatment effectiveness in real-world settings.⁷

4. Closing the gap in disease management

LDL-C (or “bad” cholesterol) is one of the most important modifiable risk factors in reducing a person’s risk of a second cardiovascular event, and studies have shown that many people who are at very high-risk are not being treated to the guidelines established by the American College of Cardiology and the American Heart Association, and more intensive efforts are needed.^8,9 To help close this gap in care, Amgen is collaborating with the American College of Cardiology and others on a national study (TRANSFORM: ACS) to help ensure that people with acute coronary syndrome (ACS) quickly receive cholesterol testing in the hospital, as well as guideline-recommended therapies to reduce LDL cholesterol in the hospital and upon discharge.¹⁰

5. Collaborating to remove barriers to treatment

Some challenges can’t be solved alone. Or even through partnerships. Some challenges are so big that they require a collective effort, like the systemic barriers that prevent many patients with cardiovascular disease from accessing PCSK9i monoclonal antibody treatments, which can lower LDL-C levels by more than 50%.¹¹ That’s why Amgen is bringing together community stakeholders to find solutions, including collaborations with the Partnership to Advance Cardiovascular Health (PACH) and the Association of Black Cardiologists. By working with PACH, Amgen is helping payers understand the impact of restrictive health plan formulary decisions on heart health outcomes, while Amgen’s collaboration with the Association of Black Cardiologists seeks to improve patient and provider understanding of evidence-based lipid management and other therapies across the cardiovascular disease spectrum and advocates for solutions to address health disparities experienced by African American patients.

Solving systemic challenges will take a concerted effort by many stakeholders, and change won’t happen overnight. Until then, Amgen is committed to helping patients afford treatment. Amgen was the first manufacturer to the lower the price of its PCSK9i in 2019 and it helps Repatha patients stay on their treatment as prescribed by their doctor through various patient support resources including a copay card program for eligible commercially insured patients.¹²

INDICATIONS

Repatha^® is indicated:

In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C

IMPORTANT SAFETY INFORMATION

Contraindication: Repatha^® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha^®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha^®.

Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha^®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha^®, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse Reactions in Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha^®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha^®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha^® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).

Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha^®, 8.2% placebo), nasopharyngitis (7.8% Repatha^®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha^®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha^® compared with 7.7% in patients that received placebo.

Immunogenicity: Repatha^® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha^®.

Please see full Prescribing Information.

References:

World Health Organization. (2021, June 11). Cardiovascular diseases (cvds). World Health Organization. Retrieved April 1, 2022, from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
Amgen. (2017, December 1). FDA Approves Amgen's Repatha^® (evolocumab) To Prevent Heart Attack And Stroke [Press Release]. https://www.amgen.com/newsroom/press-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke
Amgen Data on File. 2021.
Amgen. (2022, February 202). Amgen Business Review Meeting [Investor Presentation]. https://investors.amgen.com/static-files/6d823d7d-2fd1-405a-8c0e-22aa91bee682
Hariton, E., & Locascio, J. J. (2018). Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG : an international journal of obstetrics and gynaecology, 125(13), 1716. https://doi.org/10.1111/1471-0528.15199
Cruz-Ávila, H. A., Vallejo, M., Martínez-García, M., & Hernández-Lemus, E. (2020, August 28). Comorbidity networks in cardiovascular diseases. Frontiers. Retrieved April 1, 2022, from https://www.frontiersin.org/articles/10.3389/fphys.2020.01009/full
Amgen. (2019, November 15). Amgen And The Duke Clinical Research Institute Announce Initiation Of First Large-Scale Registry To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors [Press release]. https://www.amgen.com/newsroom/press-releases/2019/11/amgen-and-the-duke-clinical-research-institute-announce-initiation-of-first-large-scale-registry-to-evaluate-real-world-lipid-management-and-the-effectiveness-of-pcsk9-inhibitors
Understand your risks to prevent a heart attack. www.heart.org. (2022, February 10). Retrieved April 1, 2022, from https://www.heart.org/en/health-topics/heart-attack/understand-your-risks-to-prevent-a-heart-attack
Graham G. (2015). Disparities in cardiovascular disease risk in the United States. Current cardiology reviews, 11(3), 238–245. https://doi.org/10.2174/1573403x11666141122220003
American College of Cardiology. (2020, December 15). American College of Cardiology to Collaborate with Amgen, Veradigm to Optimize ACS Care [Press Release]. https://www.acc.org/about-acc/press-releases/2020/12/15/15/06/american-college-of-cardiology-to-collaborate-with-amgen-veradigm-to-optimize-acs-care
Chaudhary, R., Garg, J., Shah, N., & Sumner, A. (2017). PCSK9 inhibitors: A new era of lipid lowering therapy. World journal of cardiology, 9(2), 76–91. https://doi.org/10.4330/wjc.v9.i2.76
Amgen. (2019, October 24). Amgen To Make Repatha^® (evolocumab) Available Exclusively At Its Lower List Price Option In 2020 [Press release]. https://www.amgen.com/newsroom/press-releases/2019/10/amgen-to-make-repatha-evolocumab-available-exclusively-at-its-lower-list-price-option-in-2020.

Amgen’s Manufacturing Site in Puerto Rico Celebrates 30 Years of Producing Medicines Reaching Patients Around the World

Wed, 13 Apr 2022 00:19:18 Z

From a single building with about 30 people to more than 20 buildings and approximately 2,400 employees, Amgen’s Puerto Rico site has been instrumental in the company’s commitment to consistently and reliably deliver for patients.

In the early days, when there was just one building next to a cow farm, Maritza Mercado remembered just how small and startup-like the whole thing felt to her.

“My first day, I was greeted, and they pointed to a box and said, “OK, see that box – that’s your assignment to implement,” she said. “I was in the second-story area, and it was just a couple of tables and that’s when I realized we were creating everything from scratch.”

It was 1992 and Amgen had just announced plans to open a large manufacturing site in Juncos, Puerto Rico the following year, which came to be known as AML (Amgen Manufacturing Limited). It was a big step for the company that had been at the forefront of the cutting-edge biotech scene for 12 years running – originally under the name Applied Molecular Genetics and later shortened to Amgen.

A big reason for this expansion in Puerto Rico was because the company was making a splash in biotech. It was undergoing a major growth phase, transitioning from making medicines in a lab for patients in clinical trials to large-scale manufacturing.

Amgen had received Food and Drug Administration approval for a biologic therapy aimed at kidney disease. Then, two years later, came another biologic therapy for those undergoing cancer treatments. It was a heady time and demand was growing to the point where Amgen needed to scale up, expanding its production capacity to address these patient populations.

Mercado, who was one of the first hires at the Juncos site, had left her job at a large computer manufacturing firm’s production site in Puerto Rico to begin developing structures and guidelines for new employees that would be brought on board with Amgen quickly. Mercado said she remembered her first all staff meeting with about 30 people and one of them said to her: “You left Intel for this?”

Thirty years later, she is still at the site in Puerto Rico and believes it was one of the best decisions she ever made and laughs about the question that was posed to her back then.

Now Amgen manufactures more than two dozen medicines spread across multiple therapeutic areas with a presence in approximately 100 countries. The site in Puerto Rico now has 23 buildings and 2,400 employees. It began by servicing just one piece of the manufacturing puzzle, called “formulation, fill and finish,” and it now handles most every aspect of biologics manufacturing.

“I have felt very proud of working in HR and, as I look back, I can say one of the reasons I stayed so long is because it felt like a partnership,” Mercado said. “Working here, knowing medicines have been made and distributed to patients all over the world to help them has been gratifying. But working at Amgen has also allowed me to pay off the home we built, care for my husband who had become disabled and it helped send my children to school.”

Global Snapshot: 1992

The expansion of Amgen’s production site in Puerto Rico came amid cultural shifts around the world, within the United States and throughout Puerto Rico.

1992 was the first time that compact discs outsold cassette tapes. Also, a text-based “browser” was first made available to the public – later to be known as the World Wide Web. In science, Edmond Fischer and Edwin Krebs won the Nobel Prize for their discoveries related to reversible protein phosphorylation as a biological regulatory mechanism. And two new nations were formed: the Czech Republic and Slovakia.

It was also a year that saw Toronto Blue Jays defeat the Atlanta Braves in the World Series, Pakistan beating England in the Cricket World Cup and Steffi Graf defeating Monica Seles in the Wimbledon Finals.

Popular movies that year included “The Silence of the Lambs” and “Aladdin” while the music charts were dominated by Whitney Houston, whose ballad “I Will Always Love You” topped the Billboard charts for 14 weeks.

Around this time, Puerto Rico was getting closer to moving from U.S. territory to statehood than it had ever had since the island’s constitution being set in 1952. The island’s electorate voted Dr. Pedro Rossello, a pediatrician, as governor and gave power to his pro-statehood New Progressive Party in November 1992.

U.S. President George H.W. Bush, as one of his final acts before leaving office, was to order all federal departments to treat Puerto Rico administratively as a state. It was largely ceremonial, however.

Puerto Rico was also making news internationally as a new, 1,000-foot-wide antenna dish at the Arecibo Observatory – about two hours west of Amgen’s manufacturing site – coordinated with a giant dish in California to begin scanning outer space for radio signals that might transmit from any inhabited planets. The dish at Arecibo would eventually collapse in 2020.

Former Puerto Rico Gov. Pedro Rossallo. Photo: Larry Downing/Getty Images.

The world was also grappling with the HIV/AIDS crisis that had erupted about 10 years earlier, with annual deaths in the United States reaching their highest rate to date in 1992 with more than 194,000 deaths and in excess of 254,000 cases. The rates would continue to climb in both categories throughout the 1990s and into the mid-2000s.

In 1992, the first clinical trial of an antiretroviral began, the FDA issued new rules to fast-track new drugs based on surrogate markers of efficacy and President Bill Clinton established the White House Office of National AIDS Policy.

In the next three to five years, antiretroviral drug therapy would begin cutting the rate of deaths from the disease by 47%. And though there is no cure for HIV, death rates have decreased by 64% since its peak in 2004 as drug therapies have continued to be more effective in treating it.

AML-1 to 1.6 Million Square-Feet

Chris Hernández was one of Amgen’s early hires after the company broke ground and opened its 330,000 square-foot plant with about 200 staff members producing the company’s two breakthrough medicines.

“When I started, everybody knew everyone and we were just AML-1,” she said. “We used to have car washes and basketball and baseball games. There was a little lake with fish and turtles nearby and we would do cookouts on grills just like you would with family and friends after work.”

The Amgen senior executive assistant – who has worked hand-in-hand with all of AML’s site heads – also remembered the technology in the 1990s at the Puerto Rico site: word processors, floppy disks, and pagers. There were receptionists who sent messages to managers through a big machine in the reception area. A fax machine could be found in almost every corner of the building.

Chris Hernandez at Amgen in 1997. Photo courtesy of Chris Hernandez.

The AML-1 plant was an aseptic formulation, fill and finish plant, where the most complex part of the biologics manufacturing took place. The aseptic formulation, fill, and finish step is crucial to ensuring the sterility and integrity of biologics and requires close coordination between people working with the product, the formulation, fill and finish equipment, cleanroom facilities and sterilized components.

Ivelisse Castillo-López, who worked in quality assurance, remembered the complex and stringent safeguards required during that process, but also remembered the older technology that was pre-cell phones. She said they used walkie-talkies to communicate in the manufacturing area – easily done when it was just one building. It’s a big difference as compared to today, where there are five manufacturing plants spread over 1.6 million square feet.

“Now we are like a city,” she said.

But even up until the Opus project expansion in 2003 – which added three new buildings – there were still only 400 employees at the site. That would eventually quadruple over the decades. The Opus expansion included one of the three new buildings being used as a bulk drug substance manufacturing plant that made the active ingredient in the drugs and was the manufacturing step that occurs prior to formulation, fill and finish.

Since 1992, the Puerto Rico site has seen a $4 billion investment in expansion, making it a 24-hour-a-day, seven-days-a-week operation that accounts for the bulk of producing and distributing Amgen’s products. The expansion of the Juncos site over the years has included process development laboratories, recombinant protein production and purification, water treatment and cogeneration plants and warehouse and shipping facilities that ship drugs to approximately 100 countries around the world.

The DNA plaza at Amgen Manufacturing Limited (AML).

Omayra Báez, who began working in quality control sampling area in 1994 and when it was still known solely as a “Formulation, Fill and Finish Operation,” said she remembered how when the site was just one building, a few hundred employees, and was surrounded by open land.

Driving her gray 1988 Toyota, she would begin work at 4 a.m. in her first year at Amgen and remembered driving along the dark road, sometimes catching Selena or Madonna on the car stereo. Her job was to support aseptic core filling rooms as well as environmental monitoring before and during the filling process.

For her, the journey from temporary worker to full-time staff and then getting promoted to a team leader felt like nothing she’d experienced before.

“I remembered my beginnings as a QC sampler and then just years later leading in a company like Amgen where my vision was reached – it felt like a dream,” she said. “I studied microbiology science and in one moment I wanted to become an engineer, but with my degree in science, it allowed me to gain experience in different roles at Amgen – more than I expected. I have worked with many mentors and professionals at Amgen which have allowed me to expand my knowledge and career. As I said, it’s like a dream come true.”

Wanda Rivera, who started in the packaging area in 1997, said even a few years after opening in Puerto Rico, the shift from technology then until now has been dramatic.

“So different,” she said. “So much more automated and updated now.”

Amgen’s growth on the island also involved working with the University of Puerto Rico by helping infuse the campus with a biotech program. That investment has included training programs, money and equipment for the Biotechnology Learning Center at the University of Puerto Rico at Mayagüez.

Bob Bradway, Amgen’s chief executive officer, has visited the Juncos site multiple times in his tenure – praising it for resiliency amid Hurricane Maria and expressing appreciation for the operations teams working through the challenges of the global pandemic.

In 2020, he addressed the manufacturing site remotely and told them he was “proud of the success you’re having at AML, in continuing to serve every patient every time and also in continuing to keep each other safe” during the COVID-19 pandemic.

“So far our industry has been holding up quite well against the strain of COVID-19,” he said. “I think that reflects the extent to which companies in our industry have made the necessary investments in manufacturing.”

Brenda Torres, vice president of Amgen site operations in Puerto Rico, said she was honored to lead the team “like those before me” when the company continued to grow.

“In 2022, we will celebrate three decades of excellence, three decades of continuous improvement, three decades of commitment dedicated to improving the lives of our patients, our community and our environment,” Torres said.

Brenda Torres, vice president of Amgen site operations in Puerto Rico. Amgen file photo.

Sources: The Associated Press, The New York Times, El Nuevo Día, The World Health Organization, The Foundation for AIDS Research, UNAIDS, The Nobel Prize

Every Patient Counts, Every Story Matters

Tue, 09 Aug 2022 17:32:37 Z

When is health equitable? Here’s one definition. It’s when everyone, everywhere can be as healthy as possible regardless of where they come from, what they look like, or what language they speak. An important part of getting there begins with a deeper understanding of the challenges — sometimes universal, and sometimes unique — that individuals from historically underserved communities face. And there is perhaps no better way to do this than through hearing stories directly from those affected.

An Evolving Collaboration with StoryCorps Continues Sharing Impactful Stories

Amgen and StoryCorps have collaborated since 2016 to raise awareness through storytelling. This collaboration has provided a platform for patients and their families, advocates and healthcare providers to share compelling and often emotional stories about their experiences.

The Every Patient Counts, Every Story Matters: Health Equity Series is the next chapter in Amgen’s ongoing work with the non-profit organization StoryCorps.

The impact of hearing others’ stories is clear – 91% of people polled after listening to a StoryCorps conversation say it helped them better understand the experiences of people who are different from them.¹ The intent of this new initiative is to broaden understanding and awareness of the real-life impact of health disparities and to highlight experiences where patient empowerment, community care, support systems and health education resources have made comprehensive care and better outcomes more accessible.

Providing a Unique Platform to Share Diverse Health Experiences

For this initiative, Amgen and StoryCorps are inviting people who have been impacted by heart disease, asthma, psoriasis and lung cancer to participate in and record a one-on-one conversation with someone close to them about how they’ve supported each other. This could include speaking with a family member, friend, healthcare worker, member of a community support team or an organization they connected with during a time when they felt that certain aspects of their identity (e.g., age, race/ethnicity, gender) or access to resources impacted the quality of healthcare they received.

With participant approval, conversations will be archived at the Library of Congress, becoming part of American history, and select audio stories will be produced and amplified through an Amgen social media series.

Founded in 2003, StoryCorps has given people of all backgrounds and beliefs, in thousands of towns and cities in all 50 states, the chance to record interviews about their lives. For more information on StoryCorps, visit StoryCorps.org.

To hear stories from previous initiatives with StoryCorps, visit Amgen’s Every Patient Counts, Every Story Matters playlist on YouTube and follow Amgen on Twitter, Instagram, Facebook and LinkedIn to stay up to date on this initiative.

Amgen is working with or supporting more than 70 organizations through cross-sector collaborations, public-private partnerships and advocacy relations programs. Visit this page to learn more: Amgen Patient Advocacy and Strategic Alliances.

StoryCorps. StoryCorps Annual Report 2020. Retrieved from https://storycorpsorg-staging.s3.amazonaws.com/uploads/StoryCorps_Annual_Report_2020_Final_V4-613a1ba454dad-613a1ba454dae.pdf.

Fighting the Fight: Breaking Down Barriers to Equal Cancer Care

Mon, 11 Apr 2022 15:23:29 Z

While cancer can affect anyone, it doesn’t affect everyone equally. In the United States, people of color face an even greater cancer burden than their white counterparts due to disparities in prevention, detection, treatment and survival. Black/African American and Latino communities experience some of the lowest cancer survival rates of all ethnic groups due to several barriers to equitable care, including systemic racism and a lack of access to resources.¹

In order to challenge barriers to better health, whether they be societal, structural, or research-based, Amgen has teamed up with the American Cancer Society (ACS) and The Players’ Tribune to launch a new content series called “Fight the Fight.” This series brings together notable athletes to share their personal experiences with cancer and how they are striving to promote health equity.

Most recently, former NFL linebacker, author and host of the series “Uncomfortable Conversations with a Black Man” Emmanuel Acho sat down with Dr. Robert Winn, ACS board member and director of the VCU Massey Cancer Center, for a frank discussion about healthcare disparities in cancer and how we can work together to achieve equitable outcomes for people of color. Their discussion is now available as a three-part series centered on key topics related to the fight for equality in cancer care:

“As we continue to deliver transformative medicines that can help change expectations of cancer outcomes, it’s critical that we reach the patients who need them most, including those in historically underserved communities,” said I-Fen Chang, Vice President, Global Therapeutic Area Head, Oncology Medical at Amgen. “We are committed to breaking barriers to achieve health equity in cancer, and one way we’re working to do this is by raising awareness of health disparities, actions to take and the importance of improving diversity and achieving representation in clinical trials.”

In October 2020, Amgen launched the Representation in Clinical Research (RISE) program to create greater equity related to clinical trial diversity. The RISE team is working with key groups across Amgen and externally, including in historically marginalized communities, to diversify clinical trial investigators and remove barriers for patients to participate in clinical trials. Learn more about Amgen’s commitment to addressing health equity here, and register here for our upcoming 2022 Health Equity Summit.

Be sure to watch the full “Fight the Fight” series to hear from athletes who have been personally impacted by cancer, including NBA point guards Ricky Rubio and De’Aaron Fox, and former NFL cornerback Johnathan Joseph. For more information on the Fight the Fight series, visit www.cancer.org.

Cancer disparities. National Cancer Institute. Retrieved February 2022 from https://www.cancer.gov/about-cancer/understanding/disparities.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

Wed, 03 Aug 2022 17:57:59 Z

Darryl Sleep, Amgen's senior vice president and Global Medical and Chief Medical Officer, reflects on our industry's commitment to increasing clinical trial diversity and the steps Amgen is taking

Darryl Sleep, M.D.
Senior Vice President, Global Medical and Chief Medical Officer

Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we've already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.

Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn't a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.

I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we've taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.

We have a dedicated team

While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.

Ongoing learning to gain understanding and insights

Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.

Building foundational capabilities

Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.

New partnerships and collaborations

Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:

A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
The CEO Roundtable on Cancer's Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.

Measuring progress in our own trials

We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.

Recognizing differences in disease incidence, exposure and response to medicines

We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.

In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.

Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they're being prescribed was studied in people like them, with results that indicate they are likely to benefit. We're not there yet, but we're taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA's Principles, we'll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.

For more information, please visit Clinical Trial Diversity & Representation.

One Woman’s Inspiring Journey from Cleaning Labs to Cleaning the Planet

Fri, 22 Apr 2022 18:06:18 Z

Environmental sustainability is a passion that has stuck with Tanya Nunez, manager of Environmental Health & Safety (EH&S) at Amgen, since she was a child living on the Southern California coast, not far from where Amgen is now headquartered just outside Los Angeles.

"Growing up as a Native American, taking care of the environment was instilled in me at a young age." Nunez says. "Also, we lived near a Superfund site (a federal designation for locations in the U.S. with high levels of hazardous pollution) called Ormond Beach, one of the few remaining coastal wetlands in Southern California and home to several endangered species in Ventura County. So I saw environmental devastation firsthand."

Growing grass-roots projects into global cleanup efforts

Nunez brought that history of environmental service with her to Amgen in 2003, when she took a role cleaning laboratories for Manufacturing Support, but it wasn't until she moved to EH&S that she got the opportunity to put her passion to work for the company.

"Officially, my job was biohazardous waste disposal—I was wearing steel-toed boots, driving a flat-bed truck to pick up medical waste from different buildings," Nunez recalls. "But when the person in charge of the Medical Waste program, and Earth Day, stepped down, I took over. I was happy to support Amgen's efforts."

That was a turning point for both Tanya and certain sustainability efforts at Amgen, as she went on to spearhead several high-profile initiatives and volunteer programs for Amgen, including an Environmental Speaker series, global volunteer efforts such as annual coastal cleanup, plant restoration and trail maintenance on both the mainland and the Channel Islands, as well as Amgen's Global Environmental Champions contest. The Environmental Champions Award recognizes staff who contribute to environmental initiatives within Amgen.

"The coastal cleanup events started as a grass-roots project—my director gave me permission to organize a beach cleanup for my own team—but I soon realized that many other people were interested in participating," Nunez says. "Now it's a global effort, and we've been doing it for more than 15 years."

A recognition program that rewards Amgen staff for launching sustainability projects

This Earth Day, April 22, Nunez is taking her environmental sustainability commitments a step further by helping launch a new initiative for Amgen staff called the #HealthyPlanet Recognition Program. The program offers incentives and recognition for Amgen staff who go above and beyond to create programs and activities that support Amgen's sustainability goals, while also adding value for the organization.

What makes the new program unique is that it integrates with the company's internal employee recognition platform, so staff who implement programs or complete initiatives can receive rewards in recognition of their efforts. Some examples of #HealthyPlanet efforts that qualify for recognition include organizing local van/carpools for staff coming to an Amgen site, implementing a sustainability policy for a department, and training staff to use equipment more efficiently in ways that measurably reduce energy, water or waste for the company.

In addition to helping launch the program, Nunez was also the first recipient of a #HealthyPlanet recognition award thanks to her work improving sustainability efforts at Amgen.

"I have been very fortunate to work for an organization that lets me pursue my passion for environmental sustainability," Tanya says. "I always get excited when I have the opportunity to create something that supports the environment, and I'm so pleased that I can help get more staff engaged with our sustainability efforts."

5 Takeaways from Amgen’s Annual Health Equity Summit

Thu, 05 May 2022 16:59:21 Z

Amgen recently hosted its 9th Health Equity Summit, bringing together a wide range of voices to discuss issues around disparities in health and outcomes. Speakers at the event ranged from Amgen executives to government representatives and healthcare leaders from therapeutic areas such as oncology, cardiovascular disease, and asthma.

“Reducing health disparities has been a priority for Amgen for a long time,” Amgen CEO Bob Bradway says in his opening remarks. “Our mission is to serve patients—not white patients or Black patients, not rich patients or poor patients, but all patients. To achieve our mission, we must do everything we can to make sure that everyone who needs our medicines can get them, and that the people who participate in our clinical trials reflect the diversity of the overall patient populations that we’re trying to reach.”

Here’s a look at five takeaways from this year's summit:

1. Now is the time for action on health disparities

Racial disparities have been part of the healthcare landscape for a long time, but the COVID-19 pandemic shined a spotlight on the differences in healthcare access and outcomes among racial and ethnic minorities. “When it comes to health disparities, the time for talk has passed – we need to move toward action and understanding what works to close the equity gaps,” says Sheila L. Thorne, meeting facilitator and CEO of Multicultural Healthcare Marketing Group.

Judy Brown, senior vice president of Corporate Affairs, and head of Amgen’s Environmental, Social and Governance efforts, noted how Amgen empowers staff to develop grass roots programs while working with outside partners for advancing health equity, improving access to medicines, and addressing minority representation in clinical research. “Health equity is an aspiration, and we all can play a role in working towards that goal,” Brown says. “Let’s put together a framework for how we’re going to start ticking away at this challenge.”

2. No one can solve health inequity alone

The work that needs to be done to achieve health equity cannot be done alone by individual companies or segments of the healthcare industry. A comprehensive solution must be a collective effort, with a wide range of organizations – including those focused on patient advocacy, physician education, health care administration and policy change – empowered to work together toward solutions.

“Together, we can move the needle in addressing health inequities,” says Billy Mitchell, member of the Georgia House of Representatives and president of the National Black Caucus of State Legislators (NBCSL). “We recognize the importance of delivering messages that bring health education, care access and hope to our communities through the legislative process, but also through our partnerships. We must acknowledge that this work cannot be done alone or in silos.”

3. Comprehensive biomarker testing vital for health equity in cancer care

Health equity issues are notable in cancer care, with minority populations often experiencing worse outcomes and less access not only to care, but also to important tools like biomarker testing that could help guide therapies for certain cancers. The causes of biomarker testing disparities in diseases like lung cancer are multifactorial, with clinical trial representation, social determinants of health, insurance coverage and general lack of access to cancer screening all playing a role.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates and president of the Community Oncology Alliance (COA) spoke about a pilot program he launched in South Carolina called No One Left Alone that addresses many of these factors, including biomarker testing. “The community uptake on biomarker testing is between 25% to 48%, depending on what region you go to,” Patel says. “We reached out to two large partners in the system, and we said, ‘We need to study the disparity between the testing’, and we brought up our testing from 25% to 84%.”

4. Community health workers key to better outcomes in cardiovascular disease

There is growing evidence that the use of community health workers can help prevent cardiovascular disease by addressing social determinants of health and providing important linkages to care. But there is still a significant need for increased funding to support the growth of community health worker programs, research on their impacts, and their sustainability over the long term.

“We know that community health workers are a patient-centered approach in terms of coming from the community, understanding the needs of the community, and being members of the community,” says Yvonne Commodore-Mensah, PhD, MHS, RN, assistant professor at Johns Hopkins School of Nursing, Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology; board member, Preventive Cardiovascular Nurses Association (PCNA). “We need more sustainable funding to support the critical roles that community health workers play in our communities.”

5. Asthma rates linked to environmental racism, require culturally competent care and education

Higher rates of asthma among minorities in the U.S. are highly connected to broader societal inequities like environmental racism. “Environmental racism is essentially the inequities that we see in the way that many Black and Brown communities live,” says Yanira Cruz, MPH, DrPH, president and CEO of the National Hispanic Council on Aging (NHCOA). “The substandard housing that many of our communities live in, the limited access to parks and nature, the fact that many housing areas for Black and Brown communities have been designed on contaminated land—that leads to health problems, including asthma.”

Hispanic populations in the U.S. are among those most disproportionately impacted by asthma, and these communities often lack information about the disease, or may be hesitant to speak to their health care providers, which highlights a need for culturally competent care delivery and linguistically appropriate education. “It is important to create a space that is comfortable, that is linguistically appropriate, so that folks understand what is being given to them,” Cruz says.

To learn more about Amgen’s 9th Health Equity Summit, watch the full event here, and watch for further information on our next Health Equity Summit this October as the event moves to twice a year.

Amgen Chronicles: Supporting Working Moms

Fri, 06 May 2022 15:59:21 Z

Mothers play vital roles in many facets of society—roles that don’t always get the recognition they deserve. Support for working moms, and for the families of Amgen’s workforce, has long been part of the company’s DNA. Early into the history of Amgen, for instance, a childcare facility was set up at the company’s headquarters, now known as Camp Amgen, to accommodate working parents. For decades, the company has offered a wide range of family-oriented benefits, everything from parental leave to counseling services for college admissions.

That support has grown even wider since the COVID-19 pandemic, which caused millions of women to either lose their jobs or leave the workforce. An article published by The Pew Charitable Trusts in September 2020, reported that mothers were three times more likely than fathers to lose their jobs in the pandemic. And while, by February 2022, male workers had regained all the jobs they lost in the previous two years, more than 1 million women had yet to return to the workforce, according to analysis from the National Women's Law Center.

We’ve all been impacted by the pandemic. As a company, we have taken deliberate action to create flexibility and address the wellbeing of our staff and their families.

— Derek Miller, Amgen’s senior vice president of Human Resources

This Mother’s Day, Amgen recognizes the contributions of mothers everywhere by chronicling the stories of five women who share the challenges they have faced as parents and caregivers.

Leaders Embracing a Supportive Culture

Karin Jarperud (pictured above), country director for Amgen in Sweden, worried about taking maternity leave when her third child was born. With two older kids and a new baby, Jarperud had a lot on her mind on top of a demanding role at work. “The job of leading one of Amgen’s affiliates comes with big responsibilities, both to the staff and for our patients in Sweden,” she explains. “But the strong support that I received from my manager around my maternity leave, and also support from his manager, was outstanding.”

A colleague stepped in as acting country director while Jarperud was away, and she says his willingness to take on that additional responsibility gave her the opportunity to fully focus on her new baby and to get settled as a family with a new member.

“I am truly thankful for the trust that we built between us and the effort that he put into the role during my leave, not to mention that each and every member of the Swedish Management Team took on additional responsibility during my absence,” she says. “I am grateful to work for a company where you truly can take the time off and focus on your family fully even if you have a role with a high level of responsibility.”

From College Prep to Caregiving Support

Tanya Towns (right), senior manager, Operations, with her husband, their college-age twins and her mother-in-law.

As a mother to twins who were navigating the college application process, Tanya Towns, a senior manager in Operations for Amgen, also found herself providing caregiving support for her mother-in-law. In both cases, the robust package of benefits available to her through Amgen provided much needed guidance at times when she wasn’t sure where else to turn.

“The college prep assistance I was able to get for my kids not only helped them through the complex application process, but it also enabled them to land scholarships for the programs they were aiming for,” Towns says. “Not long after, my mother-in-law with Alzheimer’s wound up getting COVID, which accelerated her dementia, requiring us to become her primary caregivers.”

She says the elder care support she found in Amgen’s benefits catalog was invaluable in providing resources and advice when dealing with Medicare, finding a local neurologist and getting a live-in nurse, while also retrofitting their house, when time was of the essence. She also took advantage of much needed mental health support for herself through Amgen’s benefits.

“With work, stress, COVID and all these life changes, I was also able to meet with a counselor who could do virtual sessions and give me a safe space to admit that this isn’t what I thought I'd be dealing with at this point in my life,” Towns recalls. “And the flexibility I got from team and my managers helped me get through at a time when work-life balance was truly impossible.”

Flexibility for Working Mothers

When the COVID-19 pandemic reached Japan, Eriko Takechi, a supply chain manager in Amgen’s JAPAC region, found herself working full time and managing her 9- and 7-year-old daughters at home, largely on her own, as her husband’s employer didn’t offer the flexibility for him to be home as well.

Amgen’s move to flexible work arrangements for most office-based roles during the pandemic provided Takechi the flexibility she needed to manage working and parenting from home simultaneously. Amgen’s new “virtual-first” approach, known as FlexSpace, has since become the primary way of working for many staff, providing flexibility and work-life balance.

“I sometimes felt the pressure and loneliness of having to raise our children by myself while working,” Takechi says. “Since Amgen has provided an opportunity to realize the importance of work-life balance and is willing to introduce flexible work, I no longer feel that way.”

Eriko Takechi (right), supply chain manager for Amgen’s JAPAC region, with her husband and their two daughters.

Benefits Befitting Multigenerational Challenges

Nada Obeid (left), executive director, Value and Access (U.S.), with her husband and their three children.

Nada Obeid, executive director, Value and Access (U.S.), credits Amgen’s family friendly culture, as well as her own mother, for her success as both a high-profile executive and a mother of three children, including a six-year-old and two college-age children.

“My mom has been instrumental in helping me throughout my 25-year career—she has always been here for all of us,” Obeid says. “But now the roles have been reversed, and the whole family, including the kids, are now paying it forward by helping take care of my mom.”

Obeid also appreciates the family-oriented benefits Amgen provides, not just for parents with young children, but also for older, college-age kids and beyond. “The college coaching benefits have been so helpful during what is a really stressful time, with all the college applications, financial-aid requirements, and even writing their college essays—all things I probably would have been assisting with if I didn’t have that support,” she says. “My son who is already in college was even able to get resume assistance as he starts preparing for his own career in healthcare.”

Obeid says the culture of support at Amgen, along with the host of benefits available to her and her family, make it possible to support multiple generations in one household. “I don’t ever feel inhibited about taking time to visit a college or stepping away from work to take my mom to the doctor,” Obeid says. “From senior leadership to my own team, I feel like putting family first is welcomed, encouraged and simply part of our culture, especially since COVID, and as a leader of a large team, I try to make sure I’m providing that support as well.”

Managing New Motherhood in a Pandemic

Jessica Gottmer, manager, Corporate Affairs, with her son.

Jessica Gottmer, manager in Corporate Affairs at Amgen, was one of many women who found themselves having a new baby in the midst of a global pandemic, which added additional layers of stress to the experience of having a first child.

“Not only were we having a baby in a pandemic, but it was also a more challenging pregnancy because I was diagnosed with hyperemesis gravidarum,” Gottmer says. “Without Amgen’s support and the flexibility to work from home, I’m pretty certain I would have had to go on disability.”

Gottmer was also able to take maternity leave after her son was born—Amgen offers leave not only for mothers, but also for fathers and all new parents, as part of the company’s long-standing culture of support for working families.

“I’m a mom first, and I’m grateful Amgen not only accepts that but encourages me to prioritize what matters most in my life—I love that it's common to join calls and hear 'I just dropped my kids off at school,’” Gottmer says. “After having time to completely disconnect and be present with my new little one, it was stressful to think of how I’d be able to strike a balance. But the flexibility I have to work remotely and arrange childcare from home brought me a lot of relief. I get to connect with amazing colleagues doing work I love, and it doesn’t hurt that I get to sneak in some peak-a-boo between meetings.”

Celebrating a Milestone for Patients with KRAS G12C-Mutated Lung Cancer

Tue, 31 May 2022 17:09:53 Z

Nearly 40 years ago, KRAS was identified as a fundamental driver of many human cancers, but science could not yet determine how to target the protein.¹ Its smooth surface didn't appear to have anything for a targeted therapy to latch on to, which led some scientists to declare KRAS "undruggable."¹ At Amgen, our scientists always believed it was possible.

Fast forward to 2013 when scientists were able to use advanced techniques to get a clear image of the KRAS protein. That image was a revelation as it showed a small groove, a potential latching point for a molecule, and we theorized we could start to bring the pieces together.²

The dedicated scientists in Amgen Oncology's research and development group immediately began looking for a molecule that could use that groove to potentially block KRAS protein activity. Many potential candidates were synthesized and tested before sotorasib was identified.³

We focused our efforts on that one molecule – sotorasib – took a collective deep breath and went to work as quickly as possible for patients with the KRAS G12C mutation who had limited therapy options following first-line treatment.²

In less than three years from the first patient dosed to the FDA accelerated approval of LUMAKRAS^® (sotorasib) for the treatment of non-small cell lung cancer (NSCLC), we had the world's first KRAS^G12C inhibitor available to patients from the fastest clinical development program in Amgen's history.^4,5

What is LUMAKRAS^® (sotorasib)?

LUMAKRAS^® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC): that has spread to other parts of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer.
Your healthcare provider will perform a test to make sure that LUMAKRAS^® is right for you. It is not known if LUMAKRAS^® is safe and effective in children.

Important Safety Information

What should I tell my healthcare provider before taking LUMAKRAS^®?

Before taking LUMAKRAS^®, tell your healthcare provider about all your medical conditions, including if you: have liver problems; have lung or breathing problems other than lung cancer; are pregnant or plan to become pregnant. It is not known if LUMAKRAS^® will harm your unborn baby; are breastfeeding or plan to breastfeed. It is not known if LUMAKRAS^® passes into your breast milk. Do not breastfeed during treatment with LUMAKRAS^® and for 1 week after the final dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. LUMAKRAS^® can affect the way some other medicines work, and some other medicines can affect the way LUMAKRAS^® works. Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H₂ blockers during treatment with LUMAKRAS^®. Ask your healthcare provider if you are not sure.

Clinical Trial Results

In a clinical trial, 126 adults were given an oral treatment called LUMAKRAS^®. The trial evaluated how many adults responded to LUMAKRAS^®, meaning their tumors either shrank or disappeared from initial scan. The trial also measured how long the tumor responded to LUMAKRAS^®.⁶

Important Considerations: The approval of LUMAKRAS^® in these patients is based on a study that measured the size of tumor shrinkage. Talk to your doctor to see if LUMAKRAS^® is right for you.

"What was really exciting was how quickly we were able to bring everything together. It is a tremendous feeling to have been looking and looking for this needle in a haystack and when you find it, your jaw drops. It still chokes me up when I think about the impact this drug may have on patient treatment plan options." -- Brian Lanman, PhD, Director of Research, Medicinal Chemistry, Amgen

Bringing awareness to NSCLC

Our goal has been focused on providing targeted treatment options to KRAS G12C-mutated NSCLC patients by giving healthcare professionals the world's first targeted therapy for this type of cancer, which has a very poor prognosis for patients who have progressed beyond first-line treatment.¹²

Oncologists welcomed the approval of LUMAKRAS^® as an option in their toolbox.

"I would like to see all eligible NSCLC patients be tested for their biomarker status to ensure the most appropriate treatment plans. For over 40 years we have bee trying to target the KRAS G12C mutation, and for the first time, we have a targeted treatment option, LUMAKRAS, for these patients. It opens up an additional treatment paradigm." -- David M. Waterhouse, MD, MPH, medical oncologist and hematologist at Oncology Hematology Care in Cincinnati, OH

Laurie S. was one of those patiently waiting. She had been enjoying life, running her bookkeeping company and spoiling her dogs and her two cats. In late 2017, cancer was not yet on her mind.

"I was living my life, I was having a great time. I would go hiking in the National Parks, I was traveling every month." -- Laurie S., a lung cancer patient who discovered she was KRAS G12C positive

It was around that time that Laurie started coughing and was eventually diagnosed with NSCLC. After pushing for a biomarker test, two years later, she found out her cancer carried the KRAS G12C mutation. Not long after, in 2021, she learned about LUMAKRAS^® and realized that, although her mutation had been deemed undruggable, there was a targeted treatment.^1,14 Watch the video below to learn more about Laurie's journey with NSCLC.

"If it was not for that test, I would not be on this drug," Laurie, a LUMAKRAS^® patient, explained.

While not the norm a few years ago, comprehensive biomarker testing has become a component of the treatment journey for patients with NSCLC and their healthcare providers. Approximately 1 in 8 people living with NSCLC have the KRAS G12C biomarker and the only way to identify the KRAS G12C mutation is to test for it.¹⁵ KRAS G12C can be detected by various methods.¹⁶ KRAS testing is recommended by guidelines from professional societies as part of a broad comprehensive panel or targeted testing in NSCLC.¹⁷ Patients should talk to their doctor for more information on KRAS G12C and/or biomarker testing.

"This is easily the highlight of my career. It was an incredible effort across multiple functions that ultimately achieved a treatment option that may impact patients' lives and holds very special meaning to me. It's just so powerful to hear about stories of patients who are taking LUMAKRAS" -- Andrew Parsons, PhD, Principal Scientist, Process Development, Amgen

As of Q1 2022, more than 1,500 physicians in both academic and community settings across the U.S. have experience with LUMAKRAS^®.¹⁸

Approximately 80% of patients with NSCLC are being tested by their oncologists at diagnosis for the KRAS G12C mutation as of early 2022.¹⁹ We will continue to advocate for biomarker testing and discussion of results so all people with cancer have the information they need to access the most appropriate treatment plan.

Patients around the world have received LUMAKRAS^®/LUMYKRAS^® through either the clinical development program or commercial use. Worldwide, it has been approved in 40 markets including United Arab Emirates, the European Union, Switzerland, Japan and South Korea, and in Canada and Great Britain.

Today, Laurie is enjoying Florida's sunshine and hopes to travel to South Africa, Israel, Australia and New Zealand. She's quick to express her appreciation for the scientific community that brought this first-of-its-kind treatment.

"I'm going to live my life, I'm going to try to pack in as much as I can," she said. "I plan on being here a long time. I'm not going anywhere*."

Amgen's mission is to serve patients, and this is at the forefront of everything we do every day.

"What started as a lightbulb moment with a single molecule has brought us to where we are today. Thank you to all the patients and investigators who have participated in our clinical trials for LUMAKRAS" -- Dr. David Reese, Executive Vice President, Research & Development, Amgen

*Individual results may vary.

Important Safety Information Continued

LUMAKRAS^® may cause serious side effects, including:

Liver problems: LUMAKRAS^® may cause abnormal liver blood test results. Your healthcare provider should do blood tests before starting and during treatment with LUMAKRAS^® to check your liver function. Tell your healthcare provider right away if you get any signs or symptoms of liver problems, including: your skin or the white part of your eyes turns yellow (jaundice), dark or "tea-colored" urine, light-colored stools (bowel movements), tiredness or weakness, nausea or vomiting, bleeding or bruising, loss of appetite, and pain, aching, or tenderness on the right side of your stomach-area (abdomen).
Lung or breathing problems: LUMAKRAS^® may cause inflammation of the lungs that can lead to death. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough or fever.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LUMAKRAS^® if you develop side effects.

The most common side effects

The most common side effects of LUMAKRAS^® include diarrhea, muscle or bone pain, nausea, tiredness, liver problems, cough, changes in liver function tests, and changes in certain blood tests.
These are not all the possible side effects of LUMAKRAS^®. Call your doctor for medical advice about side effects.

Please see full LUMAKRAS^® Patient Information at www.LUMAKRASHCP.com/PI.

KRAS, Kirsten rat sarcoma viral oncogene homolog.

Learn more about the first targeted treatment for patients with KRAS G12C non-small cell lung cancer at www.LUMAKRAS.com.

USA-510-80984

References:

Thein KZ, et al. Ann Rev Med. 2021;72:349-364.
Ostrem JM, et al. Nature. 2013;503:548-551.
Canon J, et al. Nature. 2019;575:217-218.
Clicnicaltrials.gov. NCT03600883. www.clinicaltrials.gov. Accessed March 11, 2022.
U.S. Food and Drug Administration.www.fda.gov. Accessed March 11, 2022.
Skoulidis F, et al. N Engl J Med. 2021;384:2-5.
Eisenhauer EA, et al. European Journal of Cancer. 2009;45-232-233.
Fakih M. et al. Journal of Clinical Oncology. 2019;37:1-2.
U.S. Food and Drug Administration. www.fda.gov. Accessed March 11, 2022.
Li BT, et al. World Conference on Lung Cancer, January 2020, Singapore.
Amgen. Amgen.com. Accessed March 11, 2022.
Spira Al, et al. Lung Cancer. 2021;159:5.
Sheridan, C. Nature Biotechnology. 2021;39:1033.
Amgen 2021. LUMAKRAS^© (Sotorasib) Prescribing Information. Thousand Oaks, CA.
Data on File, Amgen; 2020.
Sherwood J, et. al., ESMO Open Cancer Horizons. 2017;2:3.
Kalemkerian GP, et. al. Journal of Clinical Oncology, 2018;36:5.
Data on File, Amgen; 2022.
Data on File, Amgen; 2022.

Cross-Sector Alliances Show Success in Empowering Both Healthcare Professionals and Patients to Improve Bone Health

Thu, 19 May 2022 00:13:37 Z

After age 50, one in three women and one in five men around the world will experience an osteoporosis-related fracture.¹ What’s more, even after their first fracture, very few people get the care they need to prevent the next one. This adds up to 9 million or more osteoporosis fractures worldwide every year.² This means two fractures have happened in the time it’s taken to read this paragraph.

Not only that, but fractures and other bone-related problems can be a concern for adults of any age living with certain health conditions. For example, women with breast cancer can be at higher risk for fractures, pain and reduced mobility.

Amgen is supporting programs and participating in collaborations with leading bone experts and patient advocates around the world to improve osteoporosis care and fracture prevention, so fewer people become part of these sobering statistics. Here is a look at how two of these programs are making headway.

Multi-year program improves post-fracture care at hundreds of medical facilities across the world

Despite the fact that one broken bone is likely to lead to another, most patients only receive care to mend a current fracture but no comprehensive care for underlying osteoporosis. One program called Capture the Fracture^® is changing that by transforming the way healthcare providers and health systems worldwide approach fracture care.

The International Osteoporosis Foundation launched the Capture the Fracture^® program in 2012. In 2019, the International Osteoporosis Foundation created the Capture the Fracture^® Partnership, a collaborative initiative with the University of Oxford, Amgen and UCB to help increase its reach and impact.

With the Capture the Fracture^® program, the International Osteoporosis Foundation set out to facilitate implementation of better post-fracture care coordination programs, such as fracture liaison services. A fracture liaison service is an interdisciplinary approach that engages the many healthcare professionals who fracture patients come in contact with when they go to a hospital because of a broken bone due to osteoporosis.

In fracture liaison service centers, patients are assessed and offered appropriate care to mitigate the risk of future fractures.⁴ The fracture liaison services approach results in fewer secondary fractures and significant savings for healthcare systems.⁵

There was already ample evidence that fracture liaison service centers are an effective and efficient way to reduce the risk of secondary fractures when the International Osteoporosis Foundation started its initiative and yet, according to the International Osteoporosis Foundation CEO Dr. Philippe Halbout, they only existed in a few pioneering countries.⁶

Capture the Fracture^® guides and encourages healthcare systems in initiating or improving existing fracture liaison services by providing resources and input on local implementation strategies. Fracture liaison service centers can become part of the Capture the Fracture^® network by completing a best practices framework audit. Members of the network share and exchange best practices so all may benefit from key learnings.

In the ten years since its inception, the Capture the Fracture^® network has grown to more than 720 fracture liaison service centers across 50 countries and it is now growing at a faster pace than ever with the number of centers doubling since the Capture the Fracture^® Partnership was created in 2019. These centers care for approximately 440,000 fragility fracture patients each year. Also, thanks to the Capture the Fracture^® program, the need for secondary fracture prevention via fracture liaison services has been recognized by health systems all over the world.

Halbout credits this success to the interactions between non-governmental organizations, academic institutions and corporate supporters and the expanded resources made available in 2019. He notes that the expertise and global networks made available through the Capture the Fracture^® Partnership has provided key local insights and has been instrumental to the expanded reach of this multi-stakeholder initiative. “In the beginning, we focused on one or two aspects of fracture liaison services, but now we have the resources to support five pillars, which has made an enormous difference,” says Halbout.

The five Capture the Fracture^® Partnership pillars focus on 1) supporting policy change at the country level, 2) delivering tailored mentorship for healthcare providers, 3) providing scalable solutions, 4) launching a digital tool called Lyosis to streamline the healthcare providers’ work, and 5) engaging with country-specific coalitions to understand and adapt to local needs.

Halbout notes what makes Capture the Fracture^® unique is both the magnitude of the initiative globally and this flexibility to adapt locally. “This is not a one-size-fits all program. We identify the common will, strategy, and interest to all work together. We also take into consideration local context, needs and expectations for each fracture liaison service center and help them with self-assessment and improvement.”

It’s clear that Halbout and his team are committed. “Ninety percent of the staff at the International Osteoporosis Foundation have a personal history related to osteoporosis, and we are all deeply committed to making a difference.” In regard to the Capture the Fracture^® program, he says “I will not be satisfied until I see each and every hospital is using the fracture liaison services approach and we’ve changed the future for osteoporosis patients for the better.”

Bone health and breast cancer organizations unite to empower women to take action

Even for healthy women, bone health risk increases with age, but for women with breast cancer there are additional considerations. Some breast cancer treatments can weaken bones and the cancer can also metastasize to the bone, increasing the risk of fractures and other bone problems.

Amgen is supporting a three-year initiative led by Susan G. Komen and American Bone Health to encourage women to initiate constructive conversations with their doctors about appropriate screening and steps to mitigate their risk of breast cancer and bone fracture.

Komen and American Bone Health began by fielding a survey to over 2,000 women, half with breast cancer, to understand differences in knowledge levels and attitudes about bone health between those living and not living with breast cancer. “The survey was extremely important, because it really helped inform how to improve communications for people who have different risk factors and concerns,” says American Bone Health executive director Cheryl Hostinak.

While it’s important to consider individual patient needs, Komen president and CEO Paula Schneider also sees the similarities in mission that make Komen and American Bone Health great partners. "Breast and bone health are both about taking conversations out of the shadows,” says Schneider. "There are three things women need to do for their bone and breast health: get your annual wellness exams, ask if you’re due for a mammogram (and schedule it today if you are) and start a conversation with your doctor about your bone health and then make a plan to maintain it.”

An email campaign, “Breast and Bone Health Matters,” gave women facts about breast and bone health along with a fracture risk calculator to help them learn about their own fracture risk. “Through learning from our email, taking the risk calculator and receiving targeted information about what to do, we have been able to activate women to talk to their healthcare provider, to get screened, and to get diagnosed,” says Hostinak. Hostinak continued, “We’re helping women take charge and get an earlier diagnosis, so they can take action before they have a fracture.”

Bone health initiatives around the globe

Amgen supports several other bone health initiatives that organizations are leading in various countries to improve local fracture care and prevention.

Despite decades of documented success, relatively few U.S. hospitals have implemented the fracture liaison services approach. The Bone Health and Osteoporosis Foundation is working with Medstar Health and Atrium Health to pilot programs at their Maryland and North Carolina locations to reduce both primary and secondary fractures by improving osteoporosis screening rates and providing personalized care plans.

Bone Health Alliance Singapore is working to improve Singapore’s osteoporosis fracture care system by accelerating collaboration across sectors to promote a holistic approach to bone health. Priorities include earlier identification of those at risk of fracture, improving patient experiences and outcomes and training a community of 300 Bone Health Ambassadors.

Working to unify intra-country efforts, Bone Health Alliance Malaysia is utilizing social media to increase public awareness and engagement in improving bone health. This Alliance is working to increase bone health screening and with it, access to bone health services and information to help prevent fractures in the local community.

The Power Bone program, working with the Chinese Society of Bone and Mineral Research, has made progress looking into the current osteoporosis management system in China with the goal of contributing to an optimized osteoporosis care pathway.

Since 2018, the National Refracture Prevention Program led by the Thai Ministry of Public Health has been driving efforts to raise the standards of osteoporosis care through implementing fracture liaison services throughout the country. The program includes training for hospital workers across 13 districts, tech and infrastructure support; a centralized patient registry and public awareness campaigns.

A program called Ora pOSSO, which translates to “Now I can,” by Europa Donna Italia, issues a call to action to empower and educate Italian women with breast cancer about the importance of fracture prevention.

References

International Osteoporosis Foundation. About osteoporosis. At: https://www.osteoporosis.foundation/patients/about-osteoporosis. Accessed April 27, 2022.
International Osteoporosis Foundation. Epidemiology. At: https://www.osteoporosis.foundation/health-professionals/fragility-fractures/epidemiology. Accessed April 27, 2022.
National Osteoporosis Foundation. Medicare cost of osteoporotic fractures. At: https://static1.squarespace.com/static/5c0860aff793924efe2230f3/t/5d77cf1e8439c80ad6497095/1568132895065/NOF_Milliman_1pager_infographic_v8.pdf. Accessed April 27, 2022.
Bonanni S, Sorensen AA, Dubin J, Drees B. The role of fracture liaison service in osteoporosis care. Mo Med. 2017;114(4):295-298.
International Osteoporosis Foundation. Break the worldwide fragility fracture cycle. At: https://www.capturethefracture.org/our-mission. Accessed May 5, 2022.
Curtis J and Silverman SL. Commentary: The five Ws of a Fracture Liaison Service: Why, who, what, where and how? In osteoporosis, we reap what we sow. Curr Osteoporos Rep. 2013;11(4): 10.1007/s11914-013-0177-9.

Do a DOUBLE TAKE to Learn the Signs of Psoriatic Arthritis

Wed, 11 May 2022 20:40:16 Z

As a former professional dancer and competitive ballroom-dance instructor, Lauren knew the importance staying in tune with her body. However, after dismissing the pains she had been feeling, blaming other factors such as exercise and work, Lauren was eventually diagnosed with psoriatic arthritis. Unfortunately, this is the story shared by many. About 1 million Americans are affected by psoriatic arthritis and the early signs of the condition are often dismissed and attributed to other lifestyle factors.

This is why Lauren has joined the DOUBLE TAKE campaign alongside pop icon and entrepreneur Lance Bass to share her personal story, raise awareness of the signs of the condition and empower people to take action when it comes to psoriatic arthritis.

Lauren’s Story

Lauren was a dance instructor and a married mom of two young boys when she started experiencing pain in her feet. She convinced herself that she had injured herself working out and thought she had broken both of her feet. While getting an x-ray, the podiatrist noticed psoriasis patches on her knees and ankle (which she had had for over 7 years) and she was referred to a rheumatologist who diagnosed her with psoriatic arthritis.

“When I found out I had a diagnosis of psoriatic arthritis, I was worried, what did it mean for my training? What does it mean for day-to-day life? Does this mean it is never going to get better?” said Lauren.

Adapting to a New Way of Life

After trying to continue with life as a dance instructor, Lauren realised she would have to leave that part of her life behind which was a devastating blow. Lauren also had to change how she was exercising to find the right balance between her fatigue and motivation to keep going. She stayed home with her two boys for a while but feeling like she had something to share with the world, Lauren decided to get her personal training certificate and become a certified nutrition coach. Lauren now trains clients full-time, in person and online.

“Personal training is a way for me to continue to be active and is more manageable than continually doing dance moves. I can now sit on a bench if I need too when I teach people which wasn’t an option before.” said Lauren. “I have found a way to work around the illness which was holding me back.”

The Importance of Doing a DOUBLE TAKE

At the time of her diagnosis, Lauren didn’t realise that psoriatic arthritis is a chronic autoimmune disease which causes swelling in the joints along with tenderness and pain and can develop in up to 30% of people who suffer from psoriasis.

“Never in a million years did I think that my itchy skin patches could be related to my excruciating joint pain.” said Lauren. “Once I found the right doctor and talked to her about available treatments and the journey through them, I started on medication and my joint pain got much better.”

For these reasons, Lauren was excited to join the Double Take campaign alongside Lance Bass to encourage people to take another look at all the symptoms they are experiencing, raise awareness of the signs of psoriatic arthritis and take action.

“The Double Take dance is a fun way for people to check the symptoms that they are feeling and potentially make a connection between them and psoriatic arthritis” said Lauren “As a former dancer I know that dance is a source of happiness for people and to use this as a way of educating people can be really impactful.”

Lauren shared this message for those living with psoriatic arthritis:

“My biggest piece of advice would be to listen to your body when you feel like something's not right, don't wait for it to get worse, and if you have any of these symptoms, tell your doctor. My story shows how my psoriatic arthritis presented but it isn’t the same for everyone. If I had known the signs earlier, I could have talked to my doctor sooner. The good news is, that thanks to science, there are treatment options that can help.”

To watch the Double Take Dance and learn more about the signs and symptoms of psoriatic arthritis visit www.PsADoubleTake.com.

Helping to Reduce the Burden of Asthma in Communities Most At-Risk

Tue, 03 May 2022 13:31:49 Z

Asthma is a complex respiratory disease that affects approximately 25 million Americans. In the U.S., the burden of asthma has disproportionately impacted some populations more than others due to different disparities. For example, Black Americans are one and a half times more likely to have asthma than white Americans, while Puerto Rican Americans are twice as likely.¹ Decades of research and public health data have extensively identified disparities in asthma prevalence and healthcare utilization along racial, ethnic, and socioeconomic lines.

Going into these communities to better address disparities and understand each population’s needs is critical to helping them achieve equitable health outcomes. Real change requires action in the form of both community-level involvement and long-term commitments.

To help make a measurable impact for people facing the highest burden of asthma, Amgen is supporting a new initiative from the Asthma and Allergy Foundation of America (AAFA) called Health Equity Advancement and Leadership (HEAL) Innovation. HEAL Innovation is a multiyear, multicity initiative that will support local organizations with different tailored programs to help patients most at-risk reduce their burden of asthma. Amgen is the exclusive sponsor of the first year with a $1 million contribution that will help four community-based pilot programs.

Ponda Motsepe-Ditshego, Amgen

“HEAL Innovation is such a unique and critical program because it will focus on helping underserved populations who have been facing stark inequities in health and the heaviest burden of asthma,” said Ponda Motsepe-Ditshego, vice president and global medical therapeutic area head, General Medicine, at Amgen. “Our shared goal with AAFA is to create lasting change in these communities with tailored programs designed to reduce the burden of asthma, increase access to new resources and make specialists more readily available.”

The HEAL Innovation sites are located in Chicago, Detroit, Los Angeles, and St. Louis. These are communities that ranked high in AAFA’s 2021 Asthma Capitals Report as the most difficult cities to live with asthma. Factors that contribute to these being difficult places to live with asthma include high rates of air pollution and poverty.

“AAFA is eager to invest in communities and local partners to improve asthma care and outcomes,” states Kenneth Mendez, AAFA’s CEO and president. “While the costs of asthma and health disparities total billions of dollars every year for Americans, we know that we can significantly improve asthma outcomes and reduce costs through investments in the community.”

Kenneth Mendez, AAFA

The tailored programs will vary by city but will include elements such as providing patients with access to specialty care, facilitating general health and wellness interventions, conducting assessments of home environments, and improving asthma self-management education.

Kathleen Slonager, AAFA - Michigan Chapter

“In Detroit, AAFA Michigan plans to develop and implement a comprehensive and holistic program that will assist people in moving from a state of illness to a state of wellness and control,” said Kathleen Slonager, executive director at AAFA - Michigan Chapter. “The funding is a tremendous boost in our ability to provide this personalized care approach for patients in our community.”

Learn more about the HEAL Innovation program at aafa.org/healthequity.

Amgen’s commitment to health equity is longstanding, from our Annual Summits to diverse partnerships across the advocacy, professional society, government, and payer communities. Amgen is supporting or advancing nearly 100 projects to improve health equity – all backed up by an Amgen investment, last year alone, of close to $12 million. HEAL Innovation adds to existing Amgen commitments in this space.

Amgen is working with, or supporting, more than 70 organizations through cross-sector collaborations, public-private partnerships and advocacy relations programs. Visit this page to learn more: Amgen Patient Advocacy and Strategic Alliances.

aafa.org/asthmadisparities

Japanese-American Staff Member Overcomes Racial Stereotyping

Wed, 25 May 2022 18:54:00 Z

In recognition of Asian American and Pacific Islander Heritage Month – and in the face of a new wave of hate crimes in the U.S. – we meet Ryan Futagaki, an Amgen sales rep. He was one of the first Japanese-Americans to play professional soccer in the U.S.

Describe your title, role and years of service at Amgen?

Sales Representative in the Integrated Specialty Sales Division based in the Columbus, Ohio area. I have been with Amgen for five years.

How would you describe your personal journey as a professional Major League Soccer (MLS) player to your role at Amgen?

I started playing soccer at the age of four. The early experience was the start of learning the importance of teamwork and helped build confidence. I always had a goal to become a professional soccer player, which kept me motivated to excel in club soccer and eventually make the U.S. Youth National Soccer Teams, Olympic Team and later play for University of California Los Angeles (UCLA).

When the Chicago Fire drafted me in 2002, I became one of the first Japanese Americans to play for that team. At the time, there were only 12 professional teams, whereas now there are 28. It was quite an accomplishment to play professionally at that time. Growing up as a fourth generation Japanese American in California, I understood the challenges that Asian Americans faced. My grandparents were in internment camps during World War II and our family lost a lot of land in California. They taught me never to give up and to persist in the face of adversity.

When my professional career with Chicago Fire ended after four years in 2006, I started exploring different career options where I could transfer my competitive spirit and support my goal-oriented mindset. Through networking with friends and colleagues, I was introduced to the medical sales profession and soon found another passion. I worked for several pharmaceutical and medical device companies in sales before landing the opportunity at Amgen. Being a part of Amgen has been incredibly rewarding. The mission of serving patients links strongly with my personal desire to help others. My father passed away when I was 22 after a nine-year battle with ALS. If you know anything about ALS, you know that this is a well-fought battle. I attribute this experience to his strong will to live and to be present for his family, as well as the care he was given by my mom. While she was his primary caregiver, my mother was diagnosed with stage IV breast cancer during that time, which she survived. I was also a caregiver to my father, and very involved in his care. During this difficult time, my parents’ attitudes towards perseverance and a positive outlook on life instilled in me a never-quit attitude. I also have quite a bit of heart disease in my family. The history of these illnesses and my ability to help change people’s lives in my current role at Amgen, drives my passion in this field every day.

Futagaki in action while playing with Chicago Fire.

While sales became my main focus, I still maintained a connection to the soccer world. In 2007, I began playing for the U.S. Beach Soccer National Team and continued to do so until 2019. This year, I was honored with becoming the Assistant Coach for the U.S. Women’s Beach National Soccer Team and continue to represent our country in this capacity. It is such an honor to continue my involvement with the sport and represent my country. Growing up in a culture with a sense of humility, I do not tend to bring up my past as a professional soccer player unless someone asks about it. However, I am very proud of my past accomplishments.

Futagaki while coaching USA Women’s Beach Soccer National Team in El Salvador 2022 and won Tournament.

What were some of the challenges that you have faced?

Growing up as an Asian American on predominately white soccer teams, I encountered being taunted and bullied. Throughout my entire professional soccer career, members of the other team and fan base would direct racial slurs and always comment on my size. The insults only drove me to want to prove naysayers wrong and served as a big part of my self-motivation. My father was a football coach and was a man with a commanding stature. I, on the other hand (5-foot-5 inches and 135 pounds) was always on the smaller side and had to learn to overcome the challenges associated with racial stereotyping. My parents and two older brothers taught me to turn negatives into positives, which has helped me in many facets of life.

Fast forward to today, the pandemic and social injustices around the world have increased tension. For example, when those in society created a stigma by referencing COVID-19 as the “Chinese virus,” that heightened the outward discrimination people were exhibiting. Public places like grocery stores and / or simply walking down the street were no longer safe spaces. There were instances where people would stare or quickly exit the line if they were standing near me in a store.

On the job, I often travel in rural areas and back roadways to interact with my customers. I see Confederate flags, viewed as a divisive symbol in history. There are people in these locations that are not comfortable or familiar with different cultures. Nonetheless, I remind myself to remain focused on work and the patients we serve.

How has the Employee Resource Group Amgen Asian Association (AAA) served as a valuable resource to you?

Amgen Asian Association has truly been a valuable and amazing resource. I did not participate or have access to groups with previous employers. Over the past couple years, it has been disheartening to hear about the increase in anti-Asian violence and other heinous incidents that other ethnic groups have faced. AAA has provided the platform to talk with others about their experiences and helped them through challenging circumstances. This group provides the opportunity to support and empower one another.

What steps are you taking to maintain your health and wellness in these socially volatile times?

I work hard to embrace the strong connection with my family’s legacy and values. I never heard my grandparents talk ill of anyone, despite what they went through. They passed on their relentless spirit and respectful attitude to my parents, who passed that along to my two brothers and me. My wife Regina and I ingrain those same qualities to our children. We teach them to treat those with kindness and respect, regardless of race, gender, sexuality, etc. I enjoy spending time with my wife and the kids and watching them enjoy their hobbies and sports brings me the greatest joy.

Futagaki with his wife (Regina) and their two children.

I am currently an Assistant Coach for a varsity girls soccer team in a Northeast Columbus suburb. At times, I find myself practicing the art of listening. We live in a complex world and younger generations are challenged with social vulnerabilities. As a coach and parent, I reinforce how important it is to embrace and celebrate our differences. To maintain my own physical and mental wellbeing, and working out four to five times per week is a big plus.

Let’s Talk Asthma: Conversation Tips

Thu, 26 May 2022 20:25:24 Z

Asthma is a complex disease, with every experience being different. Talking openly and honestly about it can help someone living with asthma manage their disease, as well as their relationships with others.

The following tips are designed to help navigate common conversations about asthma and the scenarios in which it may interfere with an activity or daily routine. It can be hard to explain how asthma interferes with "normal" life, but these important conversations are critical.

1. Share experiences

No one knows asthma and its impact better than the person living with it. Sharing personal history and severity is the first step to educating others.

2. Mention triggers

Asthma is a chronic respiratory disease that causes inflammation and narrowing of the airways which can make it hard to breathe. Irritants like smoke and dust, or allergens such as pet dander and mold can often trigger asthma. Explaining unique triggers will help others take steps to help avoid exposure.

3. Be an advocate

Frequent and honest conversations can help a person with asthma and those around them work together to find solutions and help minimize disruptions to daily life.

Click here to download the conversation guide.

There are many scenarios in which asthma may challenge a person’s daily routine or plans. Whether it’s at home, at work or out with friends, a person living with asthma is required to navigate challenging or uncomfortable situations in order to simply breathe.

A number of scenarios are outlined below representing these interpersonal interactions and situations. The conversation tips above have been applied to each scenario to demonstrate how best to work through them.

Asthma at Home

Even at home, there are situations where it’s important for someone living with asthma to set boundaries in order to minimize disruptions to their life. Guests, roommates, or even family members may not fully grasp the severity of their asthma or the living environment they need to properly manage their condition. Having a conversation about asthma can help others understand and help keep a healthy home.

Asthma at Work

Communicating with coworkers and managers about asthma is important to helping the person living with asthma manage their condition at work. Oftentimes, a colleague may not be aware of the condition and its complexities, much less the irritants and allergens a person may have to avoid. Informing people on what can cause an asthma flare-up is a first step to reducing exposure to triggers, while minimizing disruptions to the work day.

Asthma Out and About

People living with asthma can’t always control their surroundings; however, they can communicate how to pivot plans to suit their unique needs. Having a conversation about asthma can reduce the chance of exposure to triggers and lead to a better understanding amongst all parties.

For a deeper understanding of how to talk about asthma symptoms and find the right management plan, it is important for people with asthma and their loved ones talk to an asthma specialist. For asthma-related resources, educational information and tools, visit BreakTheCycle.com.

Osteoporosis By the Numbers

Tue, 24 May 2022 17:30:12 Z

Osteoporosis is a misunderstood condition that is often described as a “silent disease” because people with osteoporosis can’t necessarily feel their bones becoming weak and brittle.¹ This chronic bone disease occurs when the body loses too much bone, makes too little bone, or both.^1,2

May is National Osteoporosis Month and Amgen is aiming to help raise awareness of osteoporosis and bone fractures by sharing important facts about osteoporosis; and the statistics are alarming – osteoporosis is responsible for approximately 1.5 million people in the U.S. suffering a fracture and $19 billion in related costs every year.^3.4

Here is more information on osteoporosis by the numbers:

Every 3 seconds, someone in the world breaks a bone because of osteoporosis.⁵
In the U.S., 1 in 2 women over the age of 50 will have an osteoporosis-related bone break in her lifetime.⁶
The annual number of fractures due to osteoporosis is projected to increase from 1.9 million to 3.2 million – or 68 percent – from 2018 to 2040.⁷
Osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions.⁸
Fewer than 20 percent of women receive treatment for osteoporosis – even after breaking a bone.⁹
Amgen has been developing and bringing new osteoporosis treatments to market for the past 20 years, but unfortunately, osteoporosis treatment is oftentimes not a priority for doctors or patients.^10,11
A standard osteoporosis test, called dual-energy X-ray absorptiometry (DXA scan), can diagnose osteoporosis before a fracture occurs, but the number of physicians in the U.S. offering this test has fallen by 26 percent since 2008.¹²
Increasing DXA screening could have substantial benefits that include preventing 3.8 million fractures.⁷

To help combat the impact of osteoporosis on patients, their caregivers and the healthcare system, this year, Amgen is proud to support the Bone Health & Osteoporosis Foundation in their “Exercise to Maximize Bone Health” campaign. The organization’s efforts around National Osteoporosis Month align with Amgen’s focus on raising awareness and encouraging women to take action in support of their bone health.

This month, Bone Health & Osteoporosis Foundation will share bone-healthy activities and information, such as webinars, to encourage education, awareness and movement.

Keep osteoporosis top of mind this month, and all year by following our Twitter and Instagram channels and learn more about what you can do to better understand your bone health and share with the women in your lives.

References

National Osteoporosis Foundation. What is Osteoporosis and What Causes It? https://www.nof.org/patients/what-is-osteoporosis/. Accessed April 25, 2022.
Abrahamsen, B., Osmond, C., & Cooper, C. (2015). Journal of the American Society for Bone and Mineral Research, 30(9), 1553–1559. https://doi.org/10.1002/jbmr.2478
Office of the Surgeon General (US). Bone Health and Osteoporosis: A Report of the Surgeon General. Office of the Surgeon General 2004. https://www.ncbi.nlm.nih.gov/books/NBK45515/
Bone Health and Osteoporosis Foundation. Osteoporosis is Serious https://www.bonehealthandosteoporosis.org/patients/what-is-osteoporosis. Accessed May 4, 2022
IOF. Facts and Statistics. Available at: https://www.iofbonehealth.org/facts-statistics. Accessed April 29, 2019.
NOF. Osteoporosis Fast Facts. Available at: https://cdn.nof.org/wpcontent/uploads/2015/12/Osteoporosis-Fast-Facts.pdf.
Lewiecki EM, Ortendahl JD, Orgle-Vanderpuye J, Grauer A, Arellano J, et al. Healthcare Policy Changes in Osteoporosis Can Improve Outcomes and Reduce Costs.JBMR. 2019 Mar 15.
Cosman, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25:2359–2381.
Boytsov, N. N., et al. (2017). Patient and Provider Characteristics Associated with Optimal Post-Fracture Osteoporosis Management. American Journal of Medical Quality, 32(6), 644–654.
Amgen. (April 9, 2019). FDA Approves EVENITY™ (romosozumab-aqqg) For the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture. Retrieved from https://www.amgen.com/newsroom/press-releases/2019/04/fda-approves-evenity-romosozumabaqqg-for-the-treatment-of-osteoporosis-in-postmenopausal-women-at-high-risk-for-fracture#.
Salminen H, Piispanen P, Toth-Pal E. Arch Osteoporos. 2019;14(1):48.
Peter M. Stevens, PhD. Direct Research LLC, Medicare PSPS Master Files and Medicare 5% LDS SAF. Cost model and projections. http://www.bonehealthandosteoporosis.org/wp-content/uploads/DXA-Testing-State-slides-6-19-18.pdf. Accessed May 4, 2022.

Recognizing Asian American and Pacific Islander (AAPI) Heritage Month

Wed, 25 May 2022 19:08:43 Z

Amgen recognizes Asian American and Pacific Islander (AAPI) Heritage Month in the workplace and society. We celebrate the rich history, contributions and diverse nationalities of our colleagues within the Asian culture and the resilience of a community that has persevered through adversity.

Read more about the stories of our Asian American and Pacific Islander colleagues and our continued Diversity, Inclusion and Belonging efforts at Amgen.

Japanese-American Staff Member Overcomes Racial Stereotyping

Standing With Our Asian American and Pacific Islander Staff

We stand in solidarity with our Asian American and Pacific Islander staff.

Margaret Chu-Moyer Honored with Prestigious Portoghese Lectureship

Margaret, a VP of Research at Amgen, is the second woman and the second chemist based in industry to be honored by the American Chemical Society and the Journal of Medicinal Chemistry.

Diversity, Inclusion and Belonging at Amgen

Reflecting on the Power of Early Research During National Cancer Research Month

Fri, 20 May 2022 01:53:09 Z

To recognize the importance of lifesaving research for the millions of people affected by cancer, the American Association for Cancer Research (AACR) established May as National Cancer Research Month.

Amgen recently kicked off a new series of oncology-driven Twitter Spaces conversations called “Science in Focus.” Jean-Charles Soria, Amgen’s Oncology Therapeutic Area Head and Senior Vice President and Angela Coxon, Head of Oncology Research, discuss Amgen’s innovative approach to early research and how Amgen is working to overcome the challenges and complexities of cancer to advance transformative medicines for people affected by this disease.

We’re studying ways to deliver more firsts in oncology in order to realize continued progress. We are looking at new targets, new mechanisms of action, new technology. Pioneering new research at the earliest stages is critical to our goal of accelerating first-in-class transformative medicines.

— Jean-Charles Soria, MD, PhD, Oncology Therapeutic Area Head

Now we have so much information to both inform the development of new approaches to cancer treatment and tailor those therapies to the appropriate patient population. One exciting immuno-oncology approach that we are focused on is T-cell engagers. Amgen’s proprietary BiTE^® platform is comprised of bispecific T cell engagers, where one arm is designed to bind to a T cell and the other is designed to bind specifically to an antigen on the cancer cell. We’ve seen how this approach has been explored in hematological malignancies, and we are advancing several molecules now across several solid tumor types with high unmet need.

— Angela Coxon, Head of Oncology Research

Listen to the full conversation below, and be sure to follow Amgen Oncology on Twitter to catch our upcoming “Science in Focus” episodes.

Searching for Solutions for Cardiovascular Disease

Wed, 22 Jun 2022 15:57:32 Z

While the world was facing waves of COVID, a similar metaphor unfolded in the mind of cardiologist Adrian Hernandez, executive director of the Duke Clinical Research Institute in North Carolina. Cardiovascular disease, he says, is a "public health tsunami," but one that can be addressed if experts across disciplines work together.

Hernandez and fellow cardiologist Ken Mahaffey, who directs the Stanford Center for Clinical Research in California, launched a new consortium in 2021 called the CardioHealth Alliance to do just that. The Alliance invites multidisciplinary experts to partner to improve cardiovascular disease prevention and care.

Heart Disease is a Worldwide Problem

According to the American Heart Association, nearly half of all U.S. adults have some form of cardiovascular disease.¹ Globally, the prevalence of cardiovascular disease cases doubled from 271 million in 1990 to 523 million in 2019.²

Amgen joined the CardioHealth Alliance in late 2021 to help expedite development and implementation of evidence-based interventions that can address—and hopefully reverse—the growing burden of cardiovascular diseases. Dr. Ponda Motsepe-Ditshego from Amgen Medical Affairs, Dr. Hernandez and Dr. Mahaffey recently shared their perspectives about why it's so important to collaborate across sectors and how the Alliance can change the trajectory of cardiac diseases.

Ponda Motsepe-Ditshego, M.D.

Adrian Hernandez, M.D., M.H.S.

Ken Mahaffey, M.D.

Their comments have been edited and condensed for this article.

On the scope of the problem and the power of partnerships…

Ponda Motsepe-Ditshego: For Amgen, the decision to join and support the Alliance was an easy one because it aligns perfectly with our core belief that we need to combine our strengths and ingenuity across sectors to tackle big, complex health challenges. Cardiovascular disease certainly fits this description.

Adrian Hernandez: The Alliance was born out of a similar recognition that while we have this tsunami of cardiovascular disease, we also have clinical systems, data scientists, informatics and medical innovations that can help tackle the problem. We need to bring them together to find innovative and disruptive solutions to this complex problem.

Ken Mahaffey: The key is that Alliance members represent very different health systems, but all have a common goal – leveraging our data platforms in creative, novel ways to learn. We can learn from the data being collected in clinical practice and also how to embed research investigations in those platforms for efficient assessment of new care pathways, interventions and quality of care. This will "bend the curve" on cardiovascular outcomes and not take a decade to do it.

On learning from COVID-19, the largest acute health challenge of our time…

Adrian Hernandez: There's been so much behavioral change because of COVID-19, from widespread adoption of more diagnostic testing to more formal proactive or preventive measures. How can we turn that same set of behaviors and learned experiences towards cardiometabolic health?

I imagine, for example, having a cardiovascular dashboard like the ones that were created for COVID. With the COVID dashboard, we could watch case numbers go up and down in near real time. With cardiac disease, right now, those numbers would only go up, but we need to have that daily dashboard mindset for cardiovascular health. Our health systems — and all of us — need to be more accountable for these people behind the numbers.

We need to think about better ways to keep people from needing hospital care, of preventing bypass surgeries, and helping them avoid renal disease and dialysis. All of it starts earlier in the chain with proactive care. So that's one of the key things that we want to do, create that dashboard for cardiovascular health and get people to act to improve the outcomes in the long-term.

Ken Mahaffey: We have well established evidence for a number of cardiovascular conditions to guide clinical practice. The challenge is that clinical care is not adhering to the practice guidelines and the evidence. Simple, interactive, point of care tools like dashboards are essential to elevate care and improve patient outcomes.

On harnessing real-world data to inform best cardiac practices…

Adrian Hernandez: Every day, as patients and clinicians engage with the healthcare system, they leave a trail of data behind as part of the clinical care process. This provides us with important information about the care patients receive, whether preventive measures are working, and so on. How do we assemble that data, how do we curate it and how do we act on it? We need to turn this "real-world" data into real action.

Ken Mahaffey: The concept of learning within the health system has been around for a while. We are now at the point that we have the data tools, analytic approaches, statistical methodologies and a growing advocacy to make it a reality. The Alliance is well poised to lead!

Ponda Motsepe-Ditshego: Bringing this real-world evidence into action alongside research data can give physicians the tools they need to tailor their approach with each patient depending on individual risk factors. The Alliance can bring us closer to truly personalized medicine, which is important because not all cardiovascular disease risk factors carry the same weight for all individuals.

Adrian Hernandez: It's also important to note, real-world data doesn't just mean only the information from electronic health records anymore. It incorporates so much other digital information that's being collected in other ways outside the immediate clinical healthcare environment. This includes, for example, data from wearables or smartphones or from insurance claims and billing activities. So today, we have a world of data to learn from.

On their vision of what the future looks like if the CardioHealth Alliance fulfills its goals…

Adrian Hernandez: When we look at that dashboard, we're going to see trajectories of cardiovascular disease going down because of the work of the Alliance and its members. It'll take some time to get there, but we can monitor our success along the way, starting by measured outcomes from Alliance member institutions, and then outwardly as the evidence we generate makes its way to other providers and communities.

Ponda Motsepe-Ditshego: I see a time when the vast majority of patients with cardiovascular disease, regardless of where they are treated, are close to what's in the guidelines for good heart health. For example, getting their LDL cholesterol as low as possible and minimizing serious and expensive outcomes like hospitalization, revascularization and recurrence of cardiovascular events.

Ken Mahaffey: We absolutely have to include patients as partners in this journey. I like the "Three Es" – engage, educate and empower. It is critical that we understand, as much as possible, the patient journey through the life course of being in healthy states or confronted with disease. The patients have to understand the critical imperative of advancing our ability to collect evidence in clinical settings and the impact we can have by using these data in shared decision making.

Adrian Hernandez: To borrow from something a friend said to me recently, we all should be doing things that are interesting, innovative, and impactful. The Alliance is all of these.

Click here to learn more about the CardioHealth Alliance.

Amgen is working with or supporting more than 70 organizations through cross-sector collaborations, public-private partnerships and advocacy relations programs. Visit this page to learn more: Amgen Patient Advocacy and Strategic Alliances.

References:

Benjamin EJ, Muntner P, Alonso A, et al on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2019 update: A report from the American Heart Association. Circulation. 2019;139:e56-e528. doi.org/10.1161/CIR.0000000000000659.
Roth GA, Mensah GA, Johnson GO, et al for the GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global burden of cardiovascular diseases and risk factors, 1990-2019: Update from the GBD 2019 study. J Am Coll Cardiol. 2022;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

8 Ways $30 Million from Amgen Foundation Commitment Will Improve STEM Education Globally

Mon, 20 Jun 2022 14:49:16 Z

It was recently announced that the Amgen Foundation has more than doubled its commitment to LabXchange, a free virtual science education platform.

"Everyone needs science, and to address the challenges of our world, science needs everyone. That’s why I’m thrilled to announce the Amgen Foundation is committing an additional $30 million to LabXchange over the next three years," said Eduardo Cetlin, President of the Amgen Foundation.

"LabXchange is an online science education platform that provides science learning opportunities for students and educators worldwide. Personally, I am proud of this continued partnership with the LabXchange team at Harvard University, as it aligns with our values so closely. Together, we are inspiring future generations to transform the world through science. I know I’m not alone in my excitement for the future of this partnership."

Click above to expand.

Here are eight ways that this additional $30 million commitment will advance science education as communicated through leaders and educators who support this effort.

1. Supporting a healthy society

Judy Gawlik Brown
Chairperson of Amgen Foundation, SVP of Amgen Corporate Affairs

“Health is only truly equal when everyone can experience the benefits of science, from access to life-saving medicines to free, high-quality science education. The Amgen Foundation’s work to provide free, high-quality science education worldwide is an integral part of our commitment to society and an important element of Amgen’s ESG strategy. Through our partnerships, we are promoting health literacy through science education, and fostering the training and education of future problem solvers who will make our world a better, healthier place.”

2. Inspiring future generations

Scott Heimlich
Vice President, Amgen Foundation

“This is not just about inspiring the next generation of scientists. This is about doing so at scale. It’s about placing a powerful and free tool in the hands of educators across the world, allowing them to customize science lessons to meet the needs of their students. It’s about young people everywhere seeing themselves in science. This went from bold idea to prototype to reality in a few short years – and has already touched millions worldwide. We’re just getting started.”

3. Speaking the language

Gaurav Vazirani
LabXchange Managing Director

“Education depends on comprehension. The more clearly you can convey instruction, the better your students can learn. For me, that’s a big reason why this collaboration with the Amgen Foundation is so important. It allows us to reach students in their native language. Right now, LabXchange offers instruction in 14 languages. Over the next three years, we plan on adding content in up to 30 languages. With each language we add, we improve access to world-class science instruction for eager students around the globe.”

4. Supporting science teachers globally

Urlette Reyes
High School Science Teacher

“LabXchange was created to be a global classroom for students who are passionate about science - and classrooms need teachers. With the Amgen Foundation grant, we are building a teacher ambassador network that will provide vetted resources, professional development and networking opportunities to science instructors. When teachers have the tools and training they need, they make life-changing impacts on their students.”

5. Engaging diverse perspectives

Tamika Jean Baptiste
Vice President and Chief Diversity Officer

“Did you know of the 616 Nobel Laureates in science, only 19 are women, with just one being a woman of color? Our commitment to LabXchange will go a long way toward addressing inequality and representation in STEM. We will launch our teacher ambassador network, increase mentorship opportunities, and expand our collaboration with HBCUs (Historically Black Colleges and Universities), developing content that addresses racial inequities in STEM, education and healthcare. Broadening our network allows us to engage more perspectives on how to best educate students of all backgrounds and support teachers.”

6. Expanding accessibility

Esteban Santos
Amgen Foundation Board Member, EVP, Operations Amgen

“I believe education is a key to success and the Amgen Foundation is helping make STEM education as accessible as possible. Through our support of LabXchange, we are addressing barriers to access head-on. Materials are digital, free-of-charge, and available to anyone, anywhere with even a dial-up connection. The platform has garnered 20 million users in just two years, and with this funding we will be able to dramatically increase the platform’s reach.”

7. Personalizing the learning experience

Uma Mahajan
Upper School Science Instructor, Durham Academy

“One of the biggest priorities for me as a teacher is to make sure my students have access to classroom resources that fit their learning methods. LabXchange allows me to differentiate my teaching methods and resources based on their needs. I already can modify curriculum so that it is unique to my students, plus offer students virtual labs. The additional funding will go a long way toward helping us meet students where they are, shape their critical thinking skills, and guide them as they take on the science challenges of the future.”

8. Providing best-in-class high-quality resources

David Reese
Amgen Foundation Board Member, EVP, Research and Development Amgen

“I am thrilled to see LabXchange and the Amgen Foundation working with over 140 organizations, including Howard Hughes Medical Institute and Khan Academy to create a robust collection of high-quality, curated resources anyone can access. We currently offer over 16,000 resources and with our commitment, LabXchange will be expanding content to include data science, biotechnology, and climate change to ensure our future scientific leaders are prepared to face the toughest challenges.”

In just the two years since launch, LabXchange has already reached 20 million users and had tremendous impact on the way we learn. With this commitment LabXchange will take huge strides towards reaching 50 million users by 2025.

Our partnership with LabXchange is paving the way for a better future for us all. Visit LabXchange.org to learn more.

To learn more about the Amgen Foundation’s work, visit www.AmgenFoundation.org

Amgen Chronicles: Why Father’s Day Has New Meaning for One Dad at Amgen

Wed, 15 Jun 2022 23:00:09 Z

When Amgen regional sales director David Henze agreed his family would host a child named Dmitrijs from a Latvian orphanage in the summer of 2018, he had no idea the profound and lasting impact the decision would make on his family—and to his own understanding of what it means to be a father.

Henze and his wife already had four sons (currently aged 23, 21, 18 and 13) and the request to host Dmitrijs came from an agency that said he was seeking an experience with brothers because he had four sisters. “My wife was reading the email request that came from a friend at our boys' school, and I said, ‘we could do that—we could give a young boy an experience with brothers pretty easily,’” he recalls. “Dmitrijs came and spent six weeks with us. It was a lovely experience, but the idea of adoption never crossed our minds.”

Finding family

A year later, a family in Alabama that hosted Dmitrijs and his four sisters over the summer asked if the Henzes would consider having all five kids for the Christmas holiday. “They wound up spending three and a half weeks here, including Christmas of 2019 and the New Year’s holiday going into 2020,” Henze says. “Our boys were generous hosts, and we had a very full and fun time together.”

At the time, the Latvian children were 14, 13, 11, 9 and 8 and had been orphans for most of their lives, having lost their parents to substance abuse and domestic violence. “They were all well cared for in the orphanage, with every material thing they needed and great educations,” Henze says. “What they lacked was a sense of what genuine trust and unconditional love look like.”

Workplace flexibility, benefits, play a part

The Henzes filed their initial adoption application “just in case” because the Latvian government was about to end its international adoption program, but when the COVID-19 pandemic came, Henze and his wife had more time to consider adoption, and the workplace flexibility Amgen provided allowed them to learn more about the process. “We also found that Amgen offers financial support for adoption services, which helped ease some of our concerns about the expense,” he adds.

It was April 2020 when the Henzes began to file the large amounts of paperwork required to move forward, which took about a year to complete. “We finally went to Latvia in May of 2021 and spent four weeks in the country,” Henze says. “Thanks to Amgen’s flexible work approach, I was able to continue working while we were there. In fact, I was able to hire an entire new sales team from Latvia, working during the night there while it was daytime here.”

David Henze and his wife Laura leveraged Amgen's flexibility program and benefits to support their growing and evolving family during their international adoption journey.

“Thanks to that flexibility, we had an amazing time experiencing their culture and being with the children in their home country,” Henze adds. “Then they all came home with us on the Saturday before Father’s Day. It was such a magical experience to spend Father’s Day at a table surrounded by nine children—it felt full but complete.”

While they were gone, the Henze’s close-knit neighborhood in the Chicago area sprang into action, helping to redesign his home office space and pitching in to buy a new sectional sofa so that all 11 of them could sit together to watch movies.

A bittersweet journey

After nine months with all nine children under one roof, the three older kids said they wanted to return to their home country. “In Latvia, any child over 12 is deemed old enough to make their own decision about being adopted, and ultimately the three older children missed the life they knew and went back to Latvia.” Henze says. He accompanied them on their return.

“On April 4 of this year, however, the younger two girls, Julija and Alisa, were officially adopted and became part of our family,” Henze says. “Of course, we keep in touch with their siblings, and they will always have a home here if they wish.”

The Henze family, which includes four sons ranging from age 23 to 13, grew by two more when they adopted the girls Julija and Alisa from Latvia in April 2022.

Just before Father’s Day 2022, Henze received another emotional gift, when he traveled to Latvia yet again, this time with their new daughters to finalize the adoption and secure their U.S. citizenship. In an email from Latvia, Henze described how the orphanage village where the older children live is now hosting mothers and children who are refugees from the war in Ukraine. “Each family house of children has a few more in each room, so life for our three older Latvians is a bit more hectic, but they are doing well,” he says. “Latvia stands in strong loyalty with Ukraine, as they too were once a communist controlled nation, and have several Ukrainian flags flying in the Latvian capital city of Riga.”

“As I write this, we are departing back to America, and when the plane lands on U.S. soil, Julija and Alisa will be Henzes and proud U.S. and Latvian citizens,” he adds. “As of now, the two newest members of our household are incredibly joyful, and they love having big brothers and being part of a permanent family—they have captured the hearts and imaginations of our entire community.”

Julija and Alisa smiling at the airport on their way home from Latvia after finalizing their adoption and securing their U.S. citizenship.

At Home in California at #BIO2022

Tue, 14 Jun 2022 17:29:26 Z

For decades, the BIO International Convention has brought together some of the world most influential members of the biotechnology industry. Few places, however, feel as fitting to host such an event as California. After all, some of the first biotechnology companies, including Amgen, trace their origins back to this corner of the world.

A biotechnology innovator since 1980, Amgen has grown into one of the world's leading independent biotechnology companies, reaching millions of patients around the world. And yet, it hasn’t strayed from its California roots or its foundation in biotechnology as evidenced by its Double Helix Sponsorship of this event.

Hear more about Amgen at #BIO2022 from Ian Thompson, Senior Vice President, U.S. Business Operations:

Here’s a rundown of where you’ll find Amgen at this year’s BIO convention:

Monday, June 13, 1 p.m. PST in Room 7B: Harnessing the Power of Biotechnology on ESG Issues, Lori Hunt, Executive Director, Corporate Affairs, Environmental, Social, Governance
Tuesday, June 14, 1:45 p.m. PST in Room 5A: Complex Innovative Design - What's in a Name? A Global Perspective on the Changing Design Landscape for Clinical Trials and What This Means, May Mo, Executive Director of Biostatistics, Head of Design & Innovation
Tuesday, June 14, 2:30 p.m. PST in Theater 3: Amgen Company Presentation, Helen Kim, Executive Director, Business Development
Wednesday, June 15, 9:00 a.m. PST (Virtual): EndPoints News Fireside Chat with Zachary Brennan featuring Ian Thompson, Senior Vice President, U.S. Business Operations
Wednesday, June 15, 3 p.m. PST in Room 4: Is This the End of Global Clinical Trials? What You Need to Know to Navigate the Complex Data Privacy and National Security Restrictions Across International Markets from Europe to China, Paul Neureiter, Executive Director for International Government Affairs and Trade Policy

We will be sharing real-time updates at BIO on our Twitter handle @Amgen. You can also follow the event hashtag on Twitter #BIO2022 for news, including about Amgen.

At Medical Innovation Forum, Bob Bradway Hails Progress Against Cancer and Heart Disease

Thu, 02 Jun 2022 01:17:02 Z

On May 3, Amgen CEO Bob Bradway participated in a "fireside chat" with Bank of America biotechnology analyst Geoff Meacham at the World Medical Innovation Forum, organized by Mass General Brigham and Partners Healthcare. Bradway's session with Meacham was entitled, "Meeting the Moment: The Next Wave of Innovation in Cancer and Cardiology."

Bradway opened by declaring that we are living in "a golden moment for those who are interested in innovating and trying to solve problems that have long seemed intractable," such as cancer and cardiovascular disease, to say nothing of the novel coronavirus and COVID. "One day," he predicted, "we'll be able to look back and recognize what an incredible accomplishment it was to have so many different approaches to battling this pandemic emerge as quickly as they did."

The new wave of innovation is coming at just the right time, as the world's population continues to age and become more prone to aging-related diseases such as cancer, osteoporosis, and heart disease. The challenge posed by chronic disease has only increased over the past two and half years, as fear of COVID has deterred many people from seeking diagnosis and timely medical attention. Research suggests that "the earlier you start therapy to prevent the development of atherosclerotic disease, the better," Bradway observed, adding that currently available medicines can help prevent heart attack and stroke.

Turning to Amgen's approach to drug development, Bradway explained that the company starts with "a conviction that we understand the biology, that we have reason to believe that our approach to that biology will work in humans. We try to find diseases where the unmet medical need is high, where we think we can bring forward a big effect size. Then we proceed with the expensive clinical trials that are required to get approval and to try to meet the needs of patients." Amgen is investing heavily "in human genetics, and we've expanded that now to include other human data – proteomic data, transcriptomic data, and a variety of different sets of data – that we think we can use to better understand disease and how our medicines, prevent disease, and hopefully improve disease outcomes."

Bradway noted that Amgen entered the emerging field of bispecific T-cell engager or BiTE medicines through its acquisition of Micromet a decade ago. Since then, our company has launched one BiTE medicine targeting liquid tumors and is now working to achieve the same progress with investigational BiTEs aimed at prostate and small-cell lung cancers.

Asked about Amgen's potential interest in cell therapy, Bradway expressed optimism about long-term prospects for the field, while noting that BiTEs offer an attractive near-term option in view of their relatively lower cost of R&D and their shorter development timelines. Nevertheless, he said, "we continue to invest in [the cell therapy] space, primarily in early-stage technologies and through our venture investing arm…. We will continue to watch closely and see, as the data emerge whether the time is right to bring these on in a more comprehensive way than we have thus far."

Bradway cited Amgen's success in developing a new treatment for lung cancers that express the KRAS G12C mutation as an example of how improved molecular-level understanding of cancer can ultimately benefit patients. Although some 80% of diagnosed lung cancer patients are being screened for this mutation, fewer than half of patients advancing to second-line treatment have their KRAS status included in their electronic medical information. "The innovation is there," Bradway declared, "and shame on us if we allow the failure … to alert the physician that the appropriate mutation is present and that, therefore, an inhibitor of that mutation is an appropriate next step" for treating the patient.

Asked, finally, about Amgen's interest in looking outside the company for interesting candidate medicines, Bradway noted that the company's innovation has historically come in roughly equal parts from Amgen's own laboratories and from external partners. "It's a healthy balance of the two," he commented. "Our focus is to try to identify technologies where we think we have some skill that will be additive to what our partner has."

Behind One Biotech’s Water Conservation Efforts: Saving Every Drop

Wed, 08 Jun 2022 22:42:52 Z

His routine remained relatively unchanged: Lace up the jogging shoes, take a few gulps of water and ensure his phone was charged.

David Ladoski would be gone for about 45 minutes during his lunch break. He would stride through Amgen's site in Thousand Oaks, California, where the large independent biotech is headquartered, turn onto the bordering street and walk around the campus. It was his chance to clear his mind of complicated data and focus on the natural world around him. He'd spot hawks gliding silently in the air. On occasion, he'd gaze at the Moon silhouetted against the blue sky.

But last year, on one of his walks, he remembered what he saw when he looked down. And his engineering mind kicked back into gear.

"There was this depression in the ground," Ladoski said. "It wasn't dangerous or huge, but it was pretty noticeable. And I noticed it had eroded the ground beneath the sidewalk."

David Ladoski, am Amgen employee for more than 20 years, saw a leak and reported it quickly. He said it was important to report and every drop saved makes a difference.

Ladoski, who has been with Amgen for more than 20 years, was curious about the cause. He saw a sprinkler head that was broken. He figured it was a leak. A pretty big one, too. "I have an underground sprinkler at my house and my water bill jetted up at one point and, after some digging, found a large leak. I fixed it and my water bill went down again."

He figured Amgen might be in the same situation. When he returned from his walk, he filled out a "SEE Card," which is a mechanism Amgen has in place for staff to identify issues like this. He also notified Scott Sharts, the site manager at Thousand Oaks.

It was fixed almost immediately.

"These are important times and we can't afford to be wasting water, the most precious resource we have," Ladoski said. "I'm glad we are taking steps to try and conserve more water."

Efforts to reduce water conservation at Amgen is nothing new—but a new set of reduction target is on the radar of many employees like Ladoski and those outside the walls of Amgen.

The path at Amgen's Thousand Oaks site, where David Ladoski spotted the leak and reported it.

In fact, the company's push toward environmental, social and governance issues—which includes water conservation—was recognized in February when Amgen was named to Newsweek's list of "America's Most Responsible Companies" for the third consecutive year. It was also named to Barron's list of "America's Most Sustainable Companies" for the second consecutive year. Amgen released its ESG Report in May, which offers a comprehensive look at, among other things related to social responsibility, a summary of sustainability goals set and achieved.

Ambitious Plan

Between 2008 and 2020, Amgen reduced its water consumption by about 30% through a series of efforts that included more drought-friendly landscaping and installing low-flow toilets. Now the plan is to reduce water usage by another 40% by 2027—based off the baseline year of 2019. That targeted outcome—while not a fixed number—aims to see a volume reduction of 227 million gallons, which is roughly the equivalent of 350 Olympic-sized swimming pools.

Darin Kuida, director of EHSS Environmental Compliance, said the goals have come about out of necessity—especially in the case of drought-stricken Southern California.

"It used to be we would experience a drought and the response was 'Oh a drought.' And then the rains would come and the drought would go away," Kuida said. "Now we are experiencing this more frequently and it's becoming a long-term normal. We need to adapt our systems to the long-term, not just the short term."

The push to the ambitious reduction, he said, will take a lot of creative thinking and a team effort. Already, Amgen has put in place an Ambassador Program, where 15 employees—mostly at the executive level—are encouraging their staff at every level to integrate sustainability concepts into their business processes to reduce waste and water usage.

The ambassadors meet and share water data at global sites to find areas where reduction and offsets can occur.

David Seitz, director of engineering and an organizer of the ambassador program, said establishing water baselines are critical to tackling the challenge of water reduction. He also said it will take a series of efforts on both a large and small scale to reach the goal.

"Getting everyone's input and participation is critical," he said. "Getting the small wins can add up along with the big wins will make all the difference."

Amgen's effort to reduce water consumption over the years have included a variety of efforts, including the use of drought tolerant plants such as those featured in front of Building 29 at the company's Thousand Oaks site. Amgen file photo.

The Big Picture

Lack of water access varies around the world, with different countries and regions facing their own set of challenges.

For the Western portion of the United States, drought and water scarcity is the biggest challenge. But it is not the only place. Brazil, where Amgen has a manufacturing site, is suffering through its worst drought in nine decades. And despite having the most freshwater resources on Earth, it has lost more than 15% of its surface water since 1991, according to news reports and a collective of environmental watchdog agencies.

Turkey, which also features an Amgen manufacturing site, has also grappled with drought in recent years.

Amgen is sensitive to the environmental pressures globally. That is why the company has engaged in the global conservation effort tailored to different sites attempting to meet an overall goal.

But Seitz said the Thousand Oaks, California site is the most water-stressed site simply because of its size and location in the midst of longer stretches of dry, drought-like conditions in the American West, though sites in Rhode Island and Puerto Rico are also engaged in efforts to help the company reach water sustainability goals.

Sean Anderson, a professor of environmental science and resource management at California State University Channel Islands, said water has always been a global issue and that water rights and claims have created a patchwork of access problems that have left, according to the United Nations, 2.2 billion people lacking access to safely managed drinking water services.

In Thousand Oaks, Anderson said the evidence of seeing water resources like the Colorado River, Lake Mead and the snowpack in the Sierra Mountains all hitting record lows in recent years require large water users to not only retool their water usage for the environment's sake, but also for the bottom line.

Last year, for the first time in its history, the U.S. Bureau of Reclamation formally declared a water shortage at Lake Mead, which takes in water from the Colorado River. It is at about 40% of capacity, which has triggered stark warnings as the West remains mired in drought. And earlier this year, the journal Nature Climate Change issued a study showing the Western United States and northern Mexico are in the midst of a megadrought—one not seen in 1,200 years.

Lake Mead is at historic water level lows as the West grapples with drought. Photo: Patricia Toth McCormick/Getty Images.

The situation is so dire, water officials this April in Southern California imposed outdoor watering limits to once a week for residents and businesses in an attempt to help offset the excessively dry conditions beginning in June.

"Companies that make these changes now are getting ahead of the looming crisis," he said. "Making the changes now instead of later, when those sensors or tools to reduce water will cost three times as much, is being a responsible player and taking a rational approach to a serious problem."

What's on Tap

Jim Fisher, who heads Global Engineering's Facilities, Utilities, and Sustainability team at Amgen, said the company has identified over 100 projects worth considering; these are being reviewed for viability, including some big projects involving large utility systems such as reverse osmosis skids and cooling towers.

"We are willing to evaluate nearly anything as we look to deploy traditional and novel water conservation technologies and practices," Fisher said.

Amgen completed water studies at each of our major manufacturing sites in 2021 with external consultants to identify additional reduction opportunities. The company also established a cross-functional water sustainability team to share projects and best practices globally. And Amgen invested many hours into engineering design of high impact projects to help ensure our utilities are minimizing water use and beneficially reusing water safely.

Amgen's new facilities in Ohio and North Carolina are also being designed with state-of-the art water efficient equipment to help meet the challenge.

Maritza Shaughnessy, director Environment, Health, Safety and Sustainability, said the SEE Card system, which is in place to report at-risk conditions and behaviors, can be used by staff globally to capture environmental sustainability observations—like when they see leaks or places where water can be saved. It is a critical part toward reaching the company's goal.

Good ideas and observations can come from anywhere and staff are encouraged to do something, if they see something. The cards have been around for 15 years and it was about a decade ago that they added a category where a staff member could report environmental compliance and sustainability observations.

"It's a pivotal system," she said. "We also have to drive the culture and get people thinking about water as part of our overall mission. Our mission is to serve patients, but we have to have water do that in almost every aspect of our processes, from research to manufacturing—water is everything."

Maritza Shaughnessy, director of Environment, Health, Safety and Sustainability at Amgen.

Ladoski said the SEE Card made it easy for him to report the leaks and he said both were fixed promptly.

He said he hopes the company might have people regularly walk the site, checking for leaks as a way to help reach the conservation goals—one step and one drop at a time.

Decoding Disease

Wed, 03 Aug 2022 17:57:58 Z

When the human genome was first fully sequenced, it was hailed as an overwhelming success. Since that time there has been an enormous amount researchers have learned from the information contained in the diversity of the 3 billion base pairs that make up our genome.

But before the human genome sequence was even complete, a small Icelandic company was busy trying to understand human diversity by taking a population-scale approach to studying the human genome.

Since its founding in 1996, deCODE genetics has contributed a tremendous amount to the research community’s understanding of human genetic variation. Seeing the value of using population genomic research to understand diversity as it applies to disease was a big draw for Amgen, who acquired deCODE in 2012.

A new way to study human diversity and biology

As deCODE joined Amgen, large-scale genome sequencing was taking off. The idea of studying the human genome to better understand the biochemical pathways involved in disease provided a much better model than the current standard of studying these pathways in mice.

“The problem with mice is they aren’t terribly good at predicting what will happen in humans,” said Bob Bradway, Amgen’s CEO. “That’s one reason why it takes 10 to 15 years and costs $2.5 billion to advance a drug from the earliest stages to approval.” Amgen researchers reasoned that studying diseases in large populations rather than in preclinical models might increase the success of drug discovery and development, said Bradway. He added that a substantial portion of Amgen’s research and development pipeline is now supported by genetic insights from deCODE.

deCODE has been at the forefront of adopting new technologies, such as whole genome sequencing, and implementing them at scale. deCODE uses high-throughput sequencers (shown here) that produce both short and long read sequences. Long reads are helpful in determining structural variations, including parts of the genome that are deleted, inserted, repeated, duplicated or inverted. Short reads are less error prone.

Looking at the entire genome using Whole Genome Sequencing (WGS) allows researchers to search for changes in any part of the genome in a completely bias-free way. This means the researchers follow the data, rather than making a hypothesis that could narrow the focus to only certain areas of interest in the genome. “There is hardly anything more dangerous to a scientist than a great hypothesis,” said deCODE genetics founder, Kári Stefánsson. “You have to be humble and accept what the data give you.”

Genome wide association studies (GWAS) look for common variations in DNA’s letters, or single nucleotide polymorphisms (SNPs), across the genome. The studies then use these data to find associations between common SNP variants and diseases or other traits. Over the past decade GWAS studies have helped deCODE identify thousands of sequence variants that are associated with a whole host of traits, including BMI, height, and conditions such as cardiovascular, neurodegenerative and inflammatory diseases.

For example, the deCODE team discovered a variant in the gene TREM2 (triggering receptor expressed on myeloid cells 2), that codes for a receptor on microglial cells, which are immune cells called histiocytes that are found in the brain. The variant in TREM2 is associated with an increased risk of Alzheimer’s disease (AD). Subsequent research by deCODE suggests the variant decreases the function of TREM2. That may prevent the microglial cells from removing amyloid deposits from the brain, contributing to the pathogenesis of AD. Amyloid is a well-known protein that has been shown to accumulate and disrupt function in the brains of individuals with AD.

deCODE’s GWAS research has shown that there are many SNP variants associated with common diseases. WGS, which is a more comprehensive way of searching for variants in the genome, has shown rare variants can also associate with common diseases. While rare variants tend to show up within genes, WGS also shows there are many important ones between genes that can still have a significant impact on disease.

Population-scale studies let the data speak louder

Iceland has about 376,000 inhabitants, as well as a single-payer health care system where all phenotypic information is linked to a unique identifier. The country also has a founder effect, which occurs when a population is descended from a small number of ancestors, which reduces genetic diversity. This, along with the nation’s interest in genealogy, makes it an ideal population in which to begin to study human diversity. To date, close to 200,000 Icelanders have participated in one or more of deCODE’s research projects, contributing biological samples, health and medical information and informed consent, showing there is strong support for this kind of research from the larger community.

Blood samples of Icelanders who have participated in deCODE research studies are stored on site. deCODE also runs a phenotyping center that provides clinical assessments of patients to enhance the breadth and depth of their data collection.

Aside from Iceland, deCODE also collaborates with researchers and collects data from populations in the U.S., Europe and Japan. It’s important to have a large enough group of participants to study, since the more people you have, the more power you have to detect associations in genetic research, particularly when looking for rare variants in the genome. “deCODE has helped us move into a position to let the science tell us about the biology with the scale to let the data speak loudly enough,” said Sir Rory Collins, chief scientific officer of the UK Biobank and deCODE collaborator.

The UK Biobank began in 2006 and aims to study how genetics and the environment impact disease. The long-term research study provides access to medical and genetic data from 500,000 participants to accredited researchers around the world. deCODE, along with the Wellcome Sanger Institute, are providing whole genome sequencing for the project. Amgen is one of four corporate partners that is helping to fund the project. Amgen is also collaborating with Intermountain Healthcare, a Utah-based healthcare delivery network, and seeks to do WGS and genotype, or look for SNPs, in 500,000 individuals. “We are working to establish collaborations,” said Stefánsson. “So we collect the data from people of various backgrounds and ethnicities that we so desperately need to find insights and make discoveries that will impact the broadest range of patients and diseases.”

While there are now biobanks in many parts of the world, deCODE was a pioneer in collecting population-scale human data to understand human diversity and disease. The deCODE researchers collect participants’ blood samples to sequence. They pair this with disease data from medical records, registries and questionnaires, as well as quantitative traits such as imaging scans, lipid levels and other test results.

I believe the analytical engine that has been built here at deCODE exists in few other places in the world.

— David Reese, executive vice president, Research and Development

The challenges of data analysis

With so many samples, deCODE has also had to find a way to efficiently analyze all this data. The group has developed sophisticated computational methods that include artificial intelligence or machine learning to mine all this information. When you have such large datasets, computational analyses can find many correlations, but not all of them will be true. That is the challenge faced by groups like deCODE. “I believe the analytical engine that has been built here at deCODE exists in few other places in the world,” said David Reese, Amgen’s executive vice president for Research and Development.

During analyses, a common question is whether an environmental factor causes a disease or is simply part of the course of the disease. One way deCODE researchers are looking at this is through Mendelian Randomization (MR), a technique that assumes that genetic variants that affect an environmental factor should also lead to a proportionally similar increased risk of disease.

For example, researchers at deCODE and colleagues looked at individuals with a variant in the endothelial lipase gene, LIPG, that is linked to having higher levels of the “good” form of cholesterol, HDL. LDL, or the “bad” form of cholesterol, and HDL are among the most commonly measured biomarkers for cardiovascular disease. Elevated levels of HDL are associated with a reduced risk of myocardial infarction (MI), or heart attack. But it has not been clear if the HDL is a direct cause of this reduced risk. Using MR, the research team looked at the effects of the variant on MI risk and found no association. This led them to conclude that raising HDL cholesterol might not reduce risk of MI, challenging a commonly held assumption in medicine. It also emphasizes the limitation of using HDL cholesterol levels as a measure of MI risk.

Click above to expand.

Layering on multi-omics data

While looking at genomics has served deCODE well, there is also valuable information in other “multi-omics” data. These data can come from transcriptomics, or the study of RNA transcripts made by genes in our DNA, and proteomics, or the study of proteins that ultimately result from those transcripts. Taking a multi-omics approach allows researchers to identify, measure and understand all the biological molecules involved in health and disease.

The levels of proteins in our blood can document both the body’s biological processes as well as the impact the environment has on us. In collaboration with the UK Biobank, Amgen and deCODE are participating in one of the largest proteomic studies measuring circulating proteins to provide further insights into health and disease.

By looking at protein levels in populations with specific diseases, researchers can capture a protein risk score for that disease. The protein risk score changes over time and is likely documenting a disease process that is already progressing. Another commonly used disease risk score is the polygenic risk score, which looks at the effects of multiple sequence variants in the germline DNA that you are born with. Unlike the proteomic risk score, the polygenic score is set at birth and does not change. But the disadvantage of it is that it is most useful earlier on in life, when it can identify risk before an individual gets the disease. deCODE research has shown that polygenic risk scores were not as good as protein risk scores at predicting future disease events when calculated on a group of older individuals who have not been diagnosed with cardiovascular disease.

From left, Rory Collins (UK Biobank), Kári Stefánsson (deCODE genetics), Ray Deshaies (Amgen) and David Reese (Amgen), at a media event at the deCODE headquarters in Reykjavik, Iceland.

Traditionally researchers have used multi-omics data for drug target identification and validation in drug discovery. But only about 20% of the targets identified are druggable. That is where multispecific medicines can close the gap. While researchers may not be able to target 80% of the disease-causing proteins, cells can control every protein in the body. “Cells have figured out how to drug everything in the genome. So we take a page from nature to go after these targets,” said Ray Deshaies, Amgen’s senior vice president of Global Research. Multispecific drugs tap into these existing mechanisms and link them to target proteins involved in disease.

It is also becoming clear that multi-omics data will be highly valuable in drug development. As we age, certain protein levels change and seem to become better predictors of a disease’s progression, rather than contributing to the onset of disease. Drug developers are looking to take advantage of that knowledge to find biomarkers that are associated with individuals whose conditions are progressing quickly and could benefit most from a drug. These biomarkers could help stratify trial populations, provide more targeted treatments and ultimately save time and resources when developing drugs.

“It’s the infusion of these multi-omics techniques into the clinical trials portion of drug development that will be most illuminating, ultimately leading us toward precision medicine,” said Reese. “As deCODE genetics celebrates 25 years, to me, this isn’t an ending, but just a beginning.”

Generative Biology: Designing Biologic Medicines with Greater Speed and Success

Wed, 03 Aug 2022 17:57:57 Z

Finding a good protein drug candidate is often like finding a needle in a haystack. Researchers generally screen through thousands of proteins found in nature until they find one that comes close to doing what they want it to do. Then comes the painstaking process of optimizing that target so it does exactly what they want it to in the body without any adverse effects. All this is hard, takes lots of time and resources, and more than half the time fails to deliver a viable candidate.

What if scientists could optimize the process of designing better protein drugs faster and with greater success? Or better still, what if they could skip the process of finding a protein in nature and just design one from scratch, or de novo, to work the way they want it to? This is the promise that generative biology holds.

Generative biology starts by identifying the underlying rules that govern the way biological systems work. In the case of proteins, this means understanding their structure or the way that they fold in 3D. This is important because the way a protein folds determines its biological function. Researchers then use this protein structure and function data that they've collected over time to train computer models that use artificial intelligence (AI) and machine learning to make proteins with specific structures and functions. Building on this data, the computer models can eventually learn how to make new proteins that work the way drug developers want them to. The more data that is put into these models, the better, faster and more successful these models become at making desired proteins.

"We're moving from a search and discover mode of operation to a design and generate way of thinking about biological function and protein function," said Marissa Mock, director of the Generative Biology group in Research and Development.

Marissa Mock, director of the Generative Biology group in Research and Development.

Chris Langmead, director of Digital Biologics Discovery in Research and Development.

The term generative biology stems from generative computer models. These models take data, learn from it and generate new data—in this case new protein designs. Generative models have only recently become advanced enough to apply to the field of protein engineering. "They're good enough to start to use," said Chris Langmead, director of Digital Biologics Discovery, "but we need them to get better." He added that this will not happen overnight. "It's a process. Just like human beings get better over time, so will our models."

Much like finding a needle in a haystack, researchers have traditionally used high throughput screening systems in the lab to find proteins that have the potential to become drugs. Generative computer models can allow scientists to design needles, or specific proteins, that can be tested in the lab without even needing haystacks. The more data that goes into the models, the better the output design becomes and the fewer needles the models will need to generate.

The protein folding problem

Proteins are the building blocks of life. The human body is made up of billions of them and they are essential for every basic function – from digesting food, to moving and thinking. With 20 basic amino acid building blocks, proteins can adopt all sorts of different shapes and sizes.

Proteins come in all different shapes and sizes with wide ranging functions. This great variety provides an opportunity to design and develop many different kinds of protein-based drugs. Shown are some examples of naturally occurring proteins both within and outside of a cell. Credit: The Protein Data Bank (PDB101.rcsb.org).(Click on image for interactive view.)

For over fifty years, scientists have been working on cracking what's called the "protein folding problem." Thanks to the Human Genome Project researchers can figure out the sequence of a protein – or the order of its amino acid building blocks – based on the DNA sequence used to make that protein. But they've struggled with predicting how those long chains of amino acids fold up and carry out that protein's function in the body. This is because there are so many ways a protein can fold, so it takes massive amounts of computing power to calculate that final structure.

Once the DNA provides the instructions to make a protein, it must go from a linear string of amino acids to its final 3D folded shape to perform its function. This is a highly complex process involving multiple intermediate steps.

Traditionally most labs have determined a protein's structure using imaging techniques like x-ray crystallography, that scatter x-rays off crystallized proteins. A newer, quicker and more effective technique is cryo-electron microscopy, which quickly freezes the protein so it can be viewed with an electron microscope. But this faster technique is still no match for taking a protein's sequence and having computer models predict its structure.

On July 22, 2021, DeepMind, a subsidiary of Google's Alphabet Inc., published research on its machine learning computational approach that predicted the structures of about 100,000 proteins. The AI and machine learning system, called AlphaFold, uses large amounts of protein data to learn from so it can predict protein structures based on a protein's amino acid sequence. And while the model's predictions aren't perfect, they are getting better every day.

Within weeks of the AlphaFold publication coming out, researchers at Amgen began testing the tool and applying it to predict protein structures and identify problem areas that the group had been struggling with for years.

This LCB1 protein is shown folding into its final 3D shape. LCB1 is a computer-designed antiviral protein invented at the Institute for Protein Design. Once folded, the protein binds to the spike protein on the surface of the SARS-CoV-2 virus. It blocks the virus' ability to infect cells. Credit: Ian Haydon, Institute for Protein Design, University of Washington.

RoseTTAFold is a tool similar to AlphaFold that was developed by the Institute for Protein Design (IPD) at the University of Washington. Amgen has an ongoing collaboration with David Baker, the director of IPD, to learn about designing proteins de novo. Amgen is also partnering with external protein design companies specializing in AI, like Generate Biomedicines.

While RoseTTAFold and AlphaFold were first developed to predict protein structures, these and other tools can now also be used to model protein-protein complexes. Being able to see how proteins bind to each other is a key aspect of drug development. It's one thing to figure out how a protein folds, it's another to figure out how a protein binds a target and carries out a function.

The protein data AlphaFold and RoseTTAFold use comes from the open-source Protein Data Bank (PDB), that contains experimental 3D structure data for large biomolecules such as proteins, DNA and RNA. The proteins in the PDB come from nature. And while this data is valuable, natural proteins are a long way from a viable drug candidate. That's where the experimental wet lab comes in.

Wet lab meets dry lab

Amgen has a long history of expertise in protein engineering in the lab, from the first biotech drug the company made to today's increasingly complex biologics. Over the last decade, the company has made large investments in wet lab automation and other protein engineering technologies. Groups across the company have also collected vast amounts of data on the structures and functions of proteins that can act as drugs.

"At Amgen we know what drug-like proteins look like. We know how to make them," said Mock. "We have large amounts of legacy data and the ability to generate large amounts of targeted data to deliver not just a protein that works, but a protein that works and is a potential therapeutic for a patient."

By taking this treasure trove of wet lab protein drug data and feeding it into the generative computer models of the computational "dry lab," the goal is to have the models generate a plausible drug candidate that can then go back to the wet lab to be tested. The results of those tests can then be fed back into the computer models to improve on the predictions.

One application of this process is in the development of multispecific drugs that are engineered to bind multiple targets at once. Part of the multispecific design process involves using smaller, simpler protein antibodies that can be modified to bind these multiple targets. In 2021 Amgen acquired Teneobio, which produces smaller, simpler, single-chain antibodies ideally suited for this purpose. Machine learning models can help speed this process even further.

"For a decade, we've built a protein engineering foundation of exquisite biology, analytics and automation. And we built that foundation with the knowledge that eventually, it would be turbocharged by new science, enabling us to launch a generative loop," said Alan Russell, vice president of Biologic Therapeutic Discovery.

This generative loop can save enormous amounts of time. It is already cutting antibody discovery timelines in half and doubling the success rate of the engineered proteins emerging from that loop, said Russell. By using computers to generate specific proteins predicted to bind a target, rather than making them from scratch in the wet lab, the dry lab can also minimize the experimental work that goes into finding candidate proteins in the first place.

Alan Russell, vice president of Biologic Therapeutic Discovery in Research and Development.

Suzanne Edavettal, executive director of Protein Engineering in Research and Development.

"All that experimental work takes a very long time. It takes a lot of resources. And if we can avoid all of that, we can go much faster," said Suzanne Edavettal, executive director of Protein Engineering. Even then, a candidate drug could still end up with undesirable effects once tested in the clinic, she said.

One example is immunogenicity, or the body's immune response to the drug. The body is exceptionally good at detecting and destroying foreign compounds, but researchers don't completely understand this complex process. During drug development, immunogenicity often can't be tested until the clinical trial phase, when a lot of effort and resources have already gone into designing the drug candidate.

The hope is that machine learning can help figure out what makes a desirable protein in fewer iterations and minimize surprises that could jeopardize the drug along the way. Decreasing cycle time and increasing probability of success are two of the greatest challenges in R&D. "The whole field of data science has been around for a long time, but it has just hit this inflection point, where now it is having very practical impacts on our work in drug discovery," said Edavettal.

But ultimately, what it comes down to are the patients. "Amgen was at the forefront of the biotech revolution," said Russell. "Just as that revolution transforms patients' lives, this next wave of drug development will allow us to create the molecules that we've been dreaming of so we can again transform the lives of our patients."

Introducing Generative Biology Revolution, a New Serial Podcast from Amgen R&D Exploring How AI-Powered Protein Design Is Transforming Drug Discovery

Wed, 22 Jun 2022 17:42:01 Z

Beginning June 23, Amgen’s R&D podcast series returns with Generative Biology Revolution. Produced in partnership with The Scientist, Generative Biology Revolution explores new transformational approaches to drug discovery and development that leverage artificial intelligence (AI) and machine learning to design novel protein therapeutics.

Identifying and optimizing biologics is a slow, iterative process, where scientists must constantly tweak potential therapeutics to improve their activity and safety. In 2021, the world changed for drug research and discovery when researchers published advances that used AI and machine learning to predict the structure of human proteins. With breakthroughs like this, scientists are reimagining protein drug discovery and design where they strive to leave the guesswork behind and instead use computers to quickly tailor biological molecules for therapeutic purposes.

In this series, Ray Deshaies, Ph.D., senior vice president of Global Research at Amgen, discusses how generative biology works and how it is transforming drug discovery to make it more predictable, shorten timelines, and increase success rates of bringing potentially life-saving medicines to patients who need them most.

“Last year, our podcasts explored the role of genetics in drug discovery and how new multispecific medicines are being designed to tackle undruggable disease targets. With our new podcast series, Generative Biology Revolution, we are now looking at how the intersection of lab research and technology is being used to help scientists quickly tailor biological molecules and accelerate drug discovery,” said Deshaies. “I’m excited to share the conversations with a terrific roster of experts as we explore this exciting and evolving field.”

Joining Deshaies are leaders from Amgen and premier research institutions discussing topics ranging from explaining this new era in transformational science to how researchers are accelerating drug discovery with protein structure prediction and design.

The first episode launches June 23, and the series continues with a new episode every Thursday through July 14. You can find Generative Biology Revolution here or by subscribing to The Scientist’s series LabTalk on Apple Podcasts, Spotify, Stitcher, Google Podcasts, or wherever you like to listen.

June 23: The Cresting Wave of Transformational Science
Alan Russell, Ph.D., vice president of Biologics at Amgen

June 30: The Protein Structure Prediction Problem
Mike Nohaile, Ph.D., chief scientific officer at Generate Biomedicines

July 7: Protein Design from Scratch
David Baker, Ph.D., director of the Institute for Protein Design at the University of Washington

July 14: Accelerating Drug Discovery with Protein Design
Suzanne Edavettal, Ph.D., executive director of Protein Engineering at Amgen

In addition to the podcast series, Amgen and The Scientist will offer a live webinar with Marissa Mock, Ph.D., director of Generative Biology at Amgen, to dig deeper into the science behind the latest technologies in generative biology. Register to listen here.

Generative Biology Revolution is the third Amgen podcast produced in partnership with The Scientist. You can find the first two series, DNA Unlocked and Undruggable, here.

Our Differences Lead To Better Science

Wed, 01 Jun 2022 19:15:53 Z

During Pride month, we recognize and celebrate the contributions of our LGBTQ+ community. We are committed to taking deliberate action to create a culture of allyship where all voices are heard, respected and people feel they can be their authentic selves.

U.S. Supreme Court Decision Makes PRIDE Month "Even More Special"

Amgen's General Counsel and leader of the PRIDE Employee Resource Group share their enthusiasm over the decision.

How Amgen’s Transgender Benefits Helped One Employee—and Her Spouse

Health coverage for transgender-related issues help employees and family members feel welcome and supported during Pride Month and beyond.

What Are Your Preferred Pronouns?

3 takeaways from Amgen’s transgender and gender diversity panel.

Showing the Way

Kim and Leigh Ann Colvin both win Amgen's prestigious 'Coach of the Year' award—the first time in Amgen history it has been awarded to a married couple in the same year.

Candid Conversations: Amgen Pride – LGBTQ+ and Allies Network

In celebration of Pride Month, this video features a transparent dialogue between Jon Graham, executive vice president, general counsel & secretary, executive sponsor of Amgen PRIDE and Andy Edgar-Beltran, principal quality engineer, global chair of Amgen PRIDE.

Diversity, Inclusion and Belonging at Amgen

Smarter, Stronger, Healthier Together: Empowerment in Cancer Care

Wed, 22 Jun 2022 15:46:46 Z

June is National Cancer Survivor Month celebrating the more than 16.9 million people in the United States who have tackled the disease or who are currently in treatment. A diagnosis of cancer, like other serious illnesses, can lead to feelings of vulnerability and lack of control. According to the CDC Foundation’s EmPOWERed Health program, becoming more empowered can be an important part of an individual’s health care experience.

Research shows that patients who feel more in control and informed are more likely to go for recommended cancer screenings and engage in shared decision-making—meaning an individual and a healthcare provider play an equal (but distinct) role in healthcare decision-making.¹ This can lead to improved health outcomes.

This concept is at the heart of the CDC Foundation’s EmPOWERed Health program, supported by Amgen. The program, in its third year, is designed to provide resources and training to facilitate empowerment and shared decision-making across the cancer care continuum—from screening and prevention to treatment and survivorship, across all types of cancer.

Angela Dunbar is the Campaign Director of the EmPOWERed Health program. She is also a breast cancer survivor. Dunbar works closely with Aideé Granados, founder and CEO of ROSAesROJO, a non-profit organization supporting Hispanic women at high-risk for breast cancer through wellness and cancer prevention education and by sharing culturally relevant content. Aideé is also a breast cancer survivor.

The CDC Foundation is working with ROSAesROJO to ensure that the resources developed as part of the EmPOWERed Health program address cultural barriers to empowerment and shared decision-making, and that they are relevant and accessible to a Hispanic audience.

They recently shared their personal and professional perspectives on feeling and acting empowered.

Angela Dunbar
Director of CDC Foundation’s EmPOWERed Health program and Breast Cancer Survivor

Aidee Granados
Founder and CEO of ROSAesROJO and Breast Cancer Survivor

Why is it important for patients with a cancer diagnosis to feel empowered?

Angela Dunbar: At the time I was diagnosed with breast cancer, I was already working on the EmPOWERed Health program and had spent a lot of time exploring what ‘empowerment’ really means, what its benefits are, and the different ways individuals can become empowered. While patient empowerment is often seen as a personality trait, one study suggested there is a better way to look at this issue: patient empowerment is a skill that can be fine-tuned or even learned. While empowerment may mean different things to different people, research definitively shows that feeling and acting empowered results in better physical and mental health overall.

This really struck a chord with me. At a time when I felt very vulnerable and overwhelmed, understanding that I could grow my skills of empowerment and potentially improve my health outcomes provided much-needed confidence and hope. I soon began to arm myself with the information I needed, and I spoke to others who had been through a similar experience—I found these connections incredibly empowering.

Aideé Granados: I was diagnosed in March 2013 with a malignant, invasive carcinoma in my right breast and lymph nodes. I was 36 years old. I arrived in the U.S. one year before the cancer diagnosis—no family and friends around me, not even my in-laws. I experienced the challenge of acculturation and language barriers. I have dealt with a system that did not consider my culture, ethnicity, socioeconomics, or my roots.

I have the privilege of health insurance, family support, a basic knowledge of English, and the opportunity to study and acquire knowledge about my disease and how to tackle it. However, today in the U.S., one in four Hispanic people live below the poverty line, and Hispanic people compose 57% of the nation’s uninsured.² The pandemic has also disproportionately affected us, further reducing coverage and isolating us from preventive care for things like cancer.

Social determinants of health such as these have repercussions: cancer is the leading cause of death among this group, yet 42% of cases could be prevented with the adoption of healthier lifestyles, for example getting the recommended cancer screenings, not smoking, and improving diet and exercise.³ Furthermore, when Hispanic women and our families do access care or wellness resources, it often doesn’t consider our cultural context or home language, entrenching existing health disparities.

What challenges did you experience when it came to shared decision-making?

Aideé Granados: The language barrier made it challenging. I remember that I was writing everything down after my doctor's visits. I asked about all new medical terms, and sometimes, I asked my doctors to spell them out for me to make sure I could learn about them in my own language. It was exhausting. Some members of my medical team seemed cold and uninterested in who I was and what I was feeling emotionally, which made it difficult to feel empowered. I had the blessing of having great support from my leading oncologist, who was also an immigrant like me, but from Turkey. He could understand the value of culturally relevant medical attention to save lives, to save my life.

Angela Dunbar: Like Aideé, I was fortunate to have health insurance and a supportive network, so my challenges were more psychological. I am what you call a classic ‘pleaser’ who avoids confrontation at all costs. It was hard for me to question my doctor’s recommendations, and I had to push myself. I discovered that simply asking the ‘why’ behind my doctor’s recommendations, especially when I didn’t like them, would lead to my doctor sharing the risks and benefits behind each choice. This conversation ultimately created a way for my doctor and me to make my treatment decisions together.

How do you help empower others? And why?

Angela Dunbar: As a breast cancer survivor, I feel compelled to help others going through cancer find their voice. Sometimes that means sharing information that helps them better understand their choices and what questions to ask their doctor, and sometimes it’s just giving people permission to communicate what’s important to them, and to take an active role in treatment decision-making. I was recently mentoring a friend who was just diagnosed with breast cancer. She was so upset that her surgery date was the same day as her daughter’s year-end dance recital. I spoke with her about the importance of sharing her preferences with her doctor so decisions can be made together. She later told me she felt so silly that she didn’t think to do this on her own, but just felt paralyzed. Her doctor changed the date, and she saw her daughter’s recital! While this decision was just about timing, there are many other important decisions that are made during cancer treatment, and it’s important you feel like you can share your voice.

Aideé Granados: I feel I have a huge responsibility to other Hispanic women like me, to my beloved Hispanic community. I have witnessed how Hispanic people need empowerment. I needed empowerment. There was information out there to prevent and reduce the impact of cancer, but in English and not rooted in our Hispanic culture. And when you are talking about matters of life and death, culturally relevant content and the support of a community is crucial to saving lives.

That’s why I am so pleased to be working with the CDC Foundation on the EmPOWERed Health program. It’s refreshing to see an organization as reputable as the CDC Foundation being so proactive in addressing the needs of the Hispanic population.

Angela Dunbar: It’s so rewarding to work alongside a fellow cancer survivor, and we’re thrilled to be partnering with ROSAesROJO as we work to tailor our content to a diverse audience.

The CDC Foundation is just one of more than 70 organizations Amgen is working with or sponsoring through cross-sector collaborations, public-private partnerships and advocacy relations programs. Visit this page to learn more: Amgen Patient Advocacy and Strategic Alliances.

Kaur, JS. How Should We “Empower” Cancer Patients? (2014) Cancer. 120 (20) 3108-3110.
Kaiser Family Foundation. Key Facts about the Uninsured Population. At: https://www.kff.org/uninsured/issue-brief/key-facts-about-the-uninsured-population/. Accessed June 8, 2022.
American Cancer Society. Cancer Prevention & Early Detection Facts & Figures 2019-2020. At: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-prevention-and-early-detection-facts-and-figures/cancer-prevention-and-early-detection-facts-and-figures-2019-2020.pdf. Accessed June 8, 2022.

Taking Pride: Amgen Celebrates the Contributions of Our LGBTQ+ Colleagues

Thu, 14 Jul 2022 20:54:30 Z

During Pride month, Amgen celebrates the contributions of its LGBTQ+ colleagues to Amgen and the communities where we live and work. This year’s theme is allyship, said Andy Edgar-Beltran, principal engineer and Global Chair of the Amgen PRIDE employee resource group.

“I’m grateful to work for a company where people support and encourage their colleagues to be their authentic selves,” said Edgar-Beltran. “Too many people around the world continue to suffer the injustices of being silenced, closeted, or openly persecuted for who they are or who they love. We take pride in knowing that we work in an environment where our unique voices are heard and uplifted.”

In a visible show of allyship, Pride flags were raised at Amgen sites around the world. In addition to the traditional rainbow colors, the progress pride flag design now includes colors to represent the transgender community and people of color.

Attendees at the Amgen Thousand Oaks (ATO) flag raise ceremony, where the company is headquartered, included Jon Graham, executive vice president, general counsel & secretary, executive sponsor of Amgen PRIDE and Derek Miller, senior vice president of Human Resources. Graham recalled that his engagement as an ally began to take shape in high school and college.

“Allyship can be a journey,” he said. “It’s about understanding, supporting and taking care of other human beings.”

Amgen partners with TransCanWork, a nonprofit organization committed to advancing workplace inclusion for transgender people. As part of the collaboration, Amgen recently updated the language of some of its HR policies and revised guidelines to better address the needs of staff who are transitioning.

Gwen Cummings, Vice President of Finance, said that while it’s important to celebrate Pride month, the need for support is ongoing.

“As the proud mother of a transgender son, it has been my honor to share our family’s experience with my Amgen colleagues,” said Cummings. “Sharing our story is an important piece of my commitment to allyship and the opportunity to be truly seen and understood has contributed greatly to my sense of belonging at Amgen.”

Amgen Origins: How a Concert Wristband Led to an Easy-to-Open Drug Box for Those with Arthritis

Wed, 27 Jul 2022 18:14:33 Z

She used to go to punk rock concerts and would get that colored paper band placed around her wrist hundreds of times.

Long nights with Flogging Molly. Bad Religion. The Violent Femmes. Late nights at small venues like The Majestic Theater in Ventura, California or The Palace near the famed Capitol Records building in Hollywood. Loud drums, louder guitars and the endless energy of long-haired singers belting out rapid-fire lyrics to an audience singing them right back at the stage.

That wristband kept her in the audience. A way to prove she could be at the show. There was no moment in those shows she ever imagined that paper wristband would become the inspiration to help patients with arthritis.

Page Buchanan, who works with the Amgen Safety Net Foundation, said a few years ago she was looking at the packaging of the drug and noticed on a visit to Building 6 in Thousand Oaks, California that it seemed difficult to open. By now, years removed from her fast-paced rock concert attending days and struggling with carpel tunnel syndrome herself, she wondered how a patient with arthritis might struggle with the packaging.

She would eventually remember the concert wristband and the adhesive tab that clasped it together around her wrist and how easy it was to put on and how well it stayed on – so well that she’d have to use scissors to cut it off sometimes.

And then asked the question that changed everything: What if?

“What if I had arthritis and tried to open this?” Buchanan said. “It’s about understanding things from the patients’ perspective that leads to seeing things differently and thinking differently. I think I do that because I’ve had an unconventional path and that’s allowed me to see things in a different light.”

Thinking Outside the Box

Before 2016, Amgen patients who received the medicine through the Amgen Safety Net Foundation, got a large box filled with Styrofoam that had strict temperature requirements for the medicine’s 48 hours from packaging to porch.

Buchanan, who worked in Thousand Oaks in Corporate Philanthropy and had been with the company for seven years, sometimes liked to visit the packaging site and shoot the breeze with the packaging engineers on site. Problem solving had always appealed to her and so did seeing things from a different point of view.

She had no background in package engineering, but she quickly noticed a few things about the boxes and her mind started turning. She ran her hands over it, felt it and opened it. With a carpel tunnel syndrome condition she had developed when she was young, it wasn’t easy. She asked if she might be able to take a crack altering the packaging.

Sure, Bill Lewis recalled. Lewis, a packaging engineer at Amgen, was open to new ideas.

“I had no idea I was good at it,” Buchanan said. “But Amgen gives you permission to see something and, if you can make it better for patients, go for it. So, I took one of the boxes and began studying it.”

Over the course of 18 months studying the box, she began to find ways to improve the patient experience for opening the box, but also a way to make the packaging more environmentally friendly and cheaper to send.

One of the first things she noticed was the size of the box.

She figured making it smaller would be helpful to cut down on the shipping costs. She also saw a chance to make the box compostable rather than just trash and noted that the package had polyurethane that stuck to the cardboard and that was made up of oil. She said every time oil prices went up, so did the packaging costs.

Buchanan discovered the packaging process took 10 steps and she thought she could reduce that to four. And by building small canals in the Styrofoam for water packets to regulate the medicine’s temperature, it extended the time it could stay in the box to more than 72 hours.

Page Buchanan helped develop the new packaging for one of Amgen's medicines. Photo: Ben Depp/Getty Images

But it was the opening of the package by a patient that made her remember her concert-going days.

“It was very hard for someone with arthritis to take off the top piece of Styrofoam,” she said. “I imagined what it would be like for an elderly patient with arthritis and that’s when I thought about the concert wristbands.”

The wristband, she said, has adhesive glue so when it’s wrapped around the wrist, it stays firmly attached while hanging on the wrist. What if, she thought, you glued one end of a tab on each side of the Styrofoam and had it run up over the edge loose so all a person had to do was pull the tabs and it would lift off easily?

It worked.

Lewis said he remembered when Buchanan made the proposal.

“I sometimes think we get some really great ideas from people who are outside,” he said. “I do believe good ideas can come from anywhere and my feeling is if someone has the confidence and ability to reach out and share an idea, I say let’s do it.”

The easy-to-open packaging developed by an idea Page Buchanan had. Photo: Ben Depp/Getty Images

The blue adhesive strap has made a big difference for patients with arthritis in opening the packages delivered to them. Photo: Ben Depp/Getty Images

Still Delivering

Now in its seventh year using the new designs with the adhesive tape, the package with the arthritis medicine is delivered to patients throughout the United States through the Amgen Safety Net Foundation. When Buchanan first saw the feedback from patients, she saw and felt the weight of what making a difference means.

“When you have arthritis, your hands don’t work as easily,” Patricia D. wrote in a patient survey response to the packaging. “I’ve had other boxes where you can’t get it out of the box. The top opened nicely; the packaging stuff came out easily.”

In 2021 Amgen Safety Net Foundation provided almost $2.2 billion of Amgen medicines to qualifying patients throughout the United States. To qualify for the Amgen Safety Net Foundation, see the requirements here.

Eduardo Cetlin, executive director of corporate affairs who oversees the Amgen Safety Net Foundation, said the charitable program aims to provide the same level of commitment to patients that drives the entire enterprise.

He said Buchanan’s work fell in line with that mission perfectly and is a model of how one person can make a difference for so many.

“Page’s efforts are testament to our commitment to continuous improvement,” Cetlin said. “Her ability to see the patient as a full human being and her sincere empathy helps our team not only do what we do but embodies why we do it. We are fortunate to have her.”

The adhesive tape found in the product packaging that is delivered to patients utilizing the Amgen Safety Net Foundation. Photo: Ben Depp/Getty Images

"Amgen Origins" is a series focused on highlighting the origin stories behind innovations large and small across Amgen.

Amid "The Great Resignation" Why Some Amgen Employees Stayed

Tue, 19 Jul 2022 22:45:58 Z

There were the long commutes in the car, often in heavy traffic, as Will Murphy burned through podcasts, audiobooks and music.

“The commute would eat up three or four hours out of my day,” he said. “And there are only so many podcasts you can listen to.”

Murphy joined Amgen in January of 2020 after leaving his human resources business partner job at Netflix. It was his second go-around at Amgen and this time he chose to stay and live near Venice Beach, where he and his wife had chosen to settle after going through a series of moves prior.

The long drive, he hoped, wouldn’t last long and he believed Amgen would eventually allow him to work from home a few days a week.

Then the global pandemic hit in March 2020. Remote working became the norm. Suddenly, the time he’d been spending in the car was being put to more productive use, including a long-time focus on health and fitness as a personal trainer. As the pandemic continued, vaccines came online and companies began to have people return to offices, Amgen did what he hoped they’d do: Empowered him to continue to work as a flex commuter.

“By removing that commute, I’ve been able to leverage that time not just from a professional aspect, but it’s allowed me to reinvest in my family and my health, too,” Murphy said. “Adopting the flexible model was one key reason to stay.”

Will Murphy, director, Diversity, Inclusion & Belonging (R&D), has been with Amgen for 2 years. A flex worker, he has been able to cut down on his commutes and use that time instead to focus on his own mental and physical health. Photo: Stacy Gleason

The Great Resignation

The global pandemic upended the workplace in ways not seen in decades.

Private and publicly-held companies grappled with vaccination requirements, mask requirements and more.

It also led to workers re-evaluating their priorities and companies learning to try and meet those employees who had seen, through remote working, a better balance in their lives.

According to a recent internal survey at Amgen, 91% of people said they are happy the company made a decision to have a more flexible work model and 84% agreed that FlexSpace is a competitive advantage for Amgen to attract and retain talent. In addition, another 84% surveyed said they are more likely to remain at Amgen with the flexibility offered by FlexSpace.

The survey also showed that 85% of those asked has a favorable response to the statement “I have what I need to be productive while working in FlexSpace.” That response was a 9% increase from the December survey.

Derek Miller, senior vice president of Human Resources at Amgen, said the company’s FlexSpace Program has had several positive effects on attracting and retaining employees at the biotech company.

“Our FlexSpace program has enabled us to reach talent that was previously inaccessible due to their location while simultaneously creating additional opportunities for growth for our existing workforce,” Miller said. “Over the past two years, we’ve listened as our workforce has asked for that flexibility. While we will continue to test and learn, FlexSpace has enabled us to retain existing staff that are seeking a more flexible workplace.”

Companies that offer flexibility and create a better work-life balance engender goodwill and a sense of reciprocity between the employee and the company.

Finding the Balance

Emma Booth, global head of Business Process and Insights, at Amgen, has been with the company since 2008 and saw the stress brought about by the pandemic soon after it exploded in early 2020.

She said everyone on her team was trying to adjust to working from home and find balance in their life. Booth even found herself struggling to find balance and learning how to find time to care for herself.

Her husband, she said, was a rescue worker and she said he always told her that it was important to take care of yourself first, so you can help take care of others. Booth used to think that was selfish, but she learned that it actually had value.

So, she started running for charity. She’d always been a runner, but she decided to take time in her day to incorporate it into her routine. Booth said the company was supportive of her – not by knowing she was running, but by trusting her to get her work done. And she did the same with her team.

“I realized it was important to have that break and that healthy space and just being in that moment,” Booth said. “I encouraged my team to do the same – to find something that was for them during the day. Knowing the company provides that kind of flexibility is inspiring, but it also appeals to a new generation of workers who are tech savvy and can get work done efficiently while having time to live a life.”

Emma Booth, global head of Business Process and Insights at Amgen, has been with the company for 14 years. She is based in Switzerland. Photo: Djamila Grossman/Getty Images for Amgen

Sharing Values

While work-life balance was also a key factor for Ellen Monticello, executive director of Commercial Business Development to want to stay at Amgen through The Great Resignation, it was also the support she said she felt when it came to her life outside of her job.

She has been with Amgen for about 10 years, with a three-year break, and said remote working has been helpful while she engages in helping to train service dogs that will eventually go out into the world and assist disabled people.

The current service dog she’s training, Sandra, is mid-way through the process. Monticello said being able to work at home and take time to work with Sandra has made for a richer life experience.

Others have also found the culture of Amgen one that overlaps with their shared values.

Patrick McGlothan, director in Global Strategic Sourcing, said he’s been with Amgen for five years and the climate is completely different to the culture where he worked before. That environment, he said, was more cutthroat and there was a robotic track of success that left people like him feeling burned out and weary.

He said the mission of focusing on patients at Amgen translated to a people-first atmosphere that had the opposite effect of his previous employer, which he said was a “road warrior, never stop” mantra.

“What Amgen has done is create an environment that, in some ways, made you want to work harder because they put the patients and employees front-and-center,” McGlothan said. “I felt like what I was doing was working to help people and the company was also flexible – if you needed to start at 11 or 12 – they gave me that kind of flexibility.”

Patrick McGlothan, director in global strategic sourcing, has been with Amgen for 5 years. He said he appreciated Amgen's flexibility with work locations and times. Photo: Bob Croslin/Getty Images for Amgen

New Challenges

According to a Pew Research report released this year, 45% of those surveyed cited a lack of flexibility about when to put in hours as a reason why they left a job.

Brian Tharpe, who has been with Amgen for 33 years, said while he has appreciated the flexible workspace option, he also simply enjoys the daily challenges and constant learning that comes with his job.

As a Corporate Engineering senior manager for the commission and qualification program based at the company’s manufacturing site in Puerto Rico, Tharpe said he has always felt challenged by new opportunities. Those opportunities have led him to move all over the United States and work in different sites, including Colorado and California.

That excitement of new challenges, he said, has kept him with the company.

“In every career as long as mine, you could be subject to the lull – the chance to look around and think, should I get out?” Tharpe said. “But there is a trust thing; I trust there are always going to be new, challenging things on the horizon. Now we have new facilities coming to Ohio and North Carolina and, well it just keeps coming. I want to be there for it.”

CEO’s Advice to Amgen’s Summer Interns? Get "Fired Up" About Biotech

Wed, 27 Jul 2022 23:56:24 Z

In a session with our summer interns, Amgen CEO Bob Bradway shared his thoughts on how to build a meaningful career and answered questions about what it’s like to lead one of the world’s leading biotech companies.

Work on things that matter. Do work that you enjoy. Capitalize on what makes you unique. Challenge the status quo. And don’t wait to make an impact on the world.

This was the career advice that Amgen CEO Bob Bradway recently offered to the company’s 180 summer interns and co-ops from around the U.S. in a virtual session held on July 13.

In a talk entitled “Being in the Right Place at the Right Time,” Bradway made the case that the right place for talented people to put this advice into practice is Amgen – and that there’s never been a better time to do so than right now.

What makes Amgen the right place? Bradway noted that the company has a long, proud tradition of delivering life-changing medicines to patients suffering from serious diseases – and strong prospects to continue doing so in the future. He added that Amgen combines the resources of a large pharmaceutical company – investing more than $20 billion in R&D over the past five years, for example – with the entrepreneurial spirit of a small, scrappy biotech startup.

And why is this the right time to be joining a world leader in biotechnology? Bradway said that we are at a special moment in history in which both the need for innovative medicines (driven primarily by a rapidly aging global population) and the ability to innovate (driven by huge advances in science and technology) have never been greater.

“We are very fired up about what we see coming in our industry,” Bradway said, “and the opportunities we think Amgen is well positioned for.”

Following his prepared remarks, Bradway opened the floor to questions. Here are a few highlights:

Marisol Cortes Rodriguez asked Bradway about the innovations at Amgen that most excite him.

Less than one year ago, Bradway responded, a subsidiary of Google used artificial intelligence to solve a challenge that had bedeviled scientists for decades: predicting the structure of nearly all the proteins in the human body, which can fold themselves into a near-infinite number of combinations. The answer matters for drug developers since a protein’s structure determines its function. “This represents a game-changing moment,” Bradway said. “It’s one that we were anticipating and were anxious to participate in. And now, in less than one year, we've adopted in our day-to-day activity many of the new technologies that were used to achieve that breakthrough.” He added that Amgen is already seeing meaningful benefits in terms of opportunities to accelerate drug development and improve success rates.

Oluwabanke Shodimu asked about the challenges Bradway faces as a CEO.

“There are so many diseases that we want to make a difference in,” Bradway said, “and so many people who aren't benefiting from therapies that we already have approved. We need to ensure that we are all aligned and focused on the same priorities, and doing everything we can to educate physicians, patients, and payers about how our medicines can make a difference in the world. It's a never-ending challenge.”

Miriam Hagan asked how Bradway’s previous experience in the financial services industry helped prepare him to lead Amgen.

Bradway noted that he came to Amgen after 20 years with Morgan Stanley, where he advised healthcare companies on their capital allocation strategies. “I came with a different background from most of my peers at Amgen,” he said. “I tried to harness that experience and make sure that I was contributing different ideas to our discussions, based on that background.”

Martin Keyt asked about how Amgen approaches risk taking.

Bradway noted that biotechnology is inherently a high-risk business in which 90% of the potential new medicines that make it into human testing ultimately fail. “We take very big risks,” he said, “and hopefully they have the potential of producing big benefits for patients who are suffering from serious diseases.” Bradway added that “there is a category of risks that we don't take, and those are compliance risks. We don't take any shortcuts when it comes to our compliance responsibilities.”

Shannon Zhuang asked Bradway to share the biggest lesson he’s recently learned.

Bradway responded that the rapid pace of change in the industry requires a level of agility that can be daunting given that Amgen is in a long lifecycle business where getting a medicine to market requires an average of 10 to 15 years. “Things that seemed like wise undertakings can seem less well-founded as a result of technology changes that happen literally overnight,” he said. “This is a humbling role made all the more so by the incredible breakthroughs that are happening.”

Kartik Saigal asked Bradway how he would make the most of the experience if he were an Amgen intern today.

Bradway said he would “try to learn as much as I could about the enterprise, its mission, its values, and the strategy that it is following to deliver on its commitments.” He advised the interns to use their assignments to “get a feel for the breadth of roles that are available inside Amgen, and to decide whether this is indeed a company doing things that really matter in the world. And then, see whether you feel fired-up and excited about what you could do here.”

“It was an honor to be able to speak directly with someone as accomplished and successful as Bob,” said Kartik, a rising senior at the Georgia Institute of Technology and an intern in Amgen’s Drug Substance Technology team. “As Bob’s own career path shows, there are many non-traditional routes for landing in senior leadership roles in biotech.”

“I’ve loved working at Amgen this summer,” added Zachary Zemmel, a rising University of Chicago junior who is interning at the company’s Cambridge, Massachusetts innovation center. “I’m learning a ton about synthetic chemistry and the pharmaceutical industry more generally. I’ve particularly enjoyed working here because of how friendly everyone has been and how excited people are to share their work.”

Did you know that Bob Bradway is active on LinkedIn? Click here to follow him and see his latest posts.

Patrick Dempsey Reflects on the Power of Support for People With Cancer

Mon, 18 Jul 2022 18:13:45 Z

In 1997, actor Patrick Dempsey received the news that no one ever wants to hear – that his mother had been diagnosed with cancer. After a 17-year battle with the disease, his mother passed away, but her determination to give back to the community still serves as inspiration for Patrick and the work he does today.

In 2008, Patrick founded the Dempsey Center, a not-for-profit organization based in Maine where his mother first received treatment for her cancer. The goal of the Dempsey Center is to provide personalized, holistic support services to anyone facing the many challenges that come with a cancer diagnosis.

There's so many people diagnosed with cancer. We need something in the community and that's how the Dempsey Center started… We wanted it to feel like a hug. We all want to be hugged. We want to be loved. And I think that's why we're here ultimately is, 'How do we take care of each other?'

— Patrick Dempsey

Patrick recently sat down to record a conversation with his friend Amanda for Amgen's Every Patient Counts, Every Story Matters – a collaborative effort with the non-profit organization StoryCorps to raise awareness about different types of cancer through the sharing of personal stories. Patrick and Amanda discuss the creation of the Dempsey Center and Amanda's journey with cancer, including her experience with the Dempsey Center as a patient.

"I found the Dempsey Center and started using services during COVID, that's when I could really accept my own reality," Amanda said, reflecting on coming to terms with a cancer diagnosis during the pandemic. "Cancer has taken a lot, but it has given me a sense of self. I would prefer not to have cancer to be able to find myself, but I am grateful that it has brought me to this place."

Listen to the conversation between Patrick and Amanda below.

While science continues to explore potential cures, every cancer journey is full of challenges from many angles. As Amanda shared, cancer can feel lonely. "I feel like an incredibly privileged human being to be able to access the services and to receive the support that I did during that time. Cancer can feel like a really lonely thing, but it doesn't have to be," she noted.

In a shared mission to make life better for people affected by cancer, Amgen and Patrick Dempsey have been working together for almost 15 years to help provide patients and their families with resources to support them throughout their cancer journey. Amgen has been a presenting sponsor since the first year of the Dempsey Challenge, the organization's yearly event where participants can run, walk or bike to raise money to raise funds to help support the Dempsey Center. This year's fundraiser will take place on the weekend of September 24-25.

Check out other stories from the Every Patient Counts, Every Story Matters oncology series by visiting the playlist on YouTube, and follow Amgen Oncology's Twitter and LinkedIn channels to stay up to date. Stay tuned for the next chapter in Amgen's ongoing work with StoryCorps, a health equity series focused on cancer, cardiovascular disease and asthma rolling out this fall.

The House She Grew Up in Became a Home for Ukrainian Refugees

Wed, 13 Jul 2022 14:09:55 Z

The farmhouse had stood mostly empty for years on the outskirts of Prague.

Alena Kralikova had tried to sell it, but there just hadn't been that many inquiries about the patch of land that had once been toiled for wheat, barley and grains for decades by her family. It had fed them, sheltered them and comforted them through tough winters and oppressive regimes and again in later years through warm summers and a parliamentary democracy.

Kralikova would sometimes go out to the farmhouse along the narrow road and, when she'd enter the kitchen where her parents would prepare dinners of rabbit and bread, the memories would come flooding back. Sometimes she'd smile at what once was. Sometimes she'd cry at what it was now.

The farmhouse Alena Kralikova grew up in outside of Prague. It is now housing Ukrainians who have fled war in their home country. Photo courtesy of Alena Kralikova

Her father died three years ago and, so too, died her last living tie to the farmhouse. It was time to let it go. So, she steeled herself with those memories and signed the paperwork to let a real estate agent begin the work of finding new owners.

A few people came and looked, but there were no offers. The global pandemic had depressed the market. Kralikova also knew it was far enough outside the city that the pool of potential buyers might be smaller. So, it sat there, empty–except for the occasional visits she'd make to dust, clean and remember.

Then, in March, war came to Ukraine when the Russian army invaded the country of about 44 million.

Kralikova, an Amgen medical science liaison, watched on the news the waves of refugees as they sought safety and shelter while fleeing Russian soldiers. She wept at the sight of many women and children making their way through bombed-out streets. She saw neighboring Poland begin taking in so many of those escaping their homes often left in piles of smoldering rubble.

She said she heard of some other Amgen employees opening their homes to refugees, trying to provide a small bit of light in a depressingly dark time.

Kralikova thought about the farmhouse. Just sitting there. Vacant. She thought about all the Ukrainians she had known in Prague over the years. She said her cleaning lady had been from Ukraine. Some construction workers she had known were from Ukraine, too. She wondered if they had relatives who were fleeing the Russian invasion.

So, she made a phone call to a Ukrainian friend. Perhaps, she thought, there might be a way for the empty farmhouse to become a home again.

Yes, came the reply. Most definitely, yes.

'Can You Accommodate Five More?'

About 7 million refugees have fled Ukraine, with Poland taking in 3.6 million – by far the most of any nearby country in Europe.

The scope of the displacement of so many drew worldwide attention and Frans Timmermans, vice president of the European Commission, praised the European response and singled out Poland's efforts amid the crisis.

"I have seldom felt so emotional than the moment I saw Polish people receiving the refugees at the border with tea, taking them into their homes. Incredible. And that makes me a proud European," said Frans Timmermans, vice president of the European Commission, according to a report in Politico.

But with services in Poland straining to handle a 10% jump in its population in just a few short weeks, other countries around Ukraine also began to take in refugees.

According to the United Nations, Hungary took in more than 650,000 while Romania took in about 600,000. The Czech Republic, which already had a sizable Ukrainian population, had taken in close to 400,000. The United Nations also reported that 13 million people are currently stranded inside Ukraine, unable to leave due to heightened risks amid the invasion. Women and children make up 90% of those who are escaping.

The global community as a whole has been rallying to help as well while many multi-national companies were either pulling out or freezing their activities in Russia.

Amgen, which has a limited presence in Russia with no manufacturing facilities or laboratories, only continues to provide medicines to patients there as they are considered "essential medicines to treat serious illness like cancer and heart disease." Amgen has also suspended all non-essential activity in Russia while also halting enrollment in all Amgen-sponsored clinical trials.

The Amgen Foundation approved two disaster relief grants to the International Medical Corps and Project Hope while also opening the Amgen Foundation Disaster Relief Matching Gifts Program to its entire staff. As of June 1, between staff donations and matching contributions, $300,000 has been contributed to the program.

But some who are closer geographically to Ukraine thought they might be able to do even more.

I can never forget their faces when they arrived. They were shy. Totally lost. We cried together. I didn't know how to act, so I tried to open my arms and I only told them this is my house, but now it is your house and everything is yours.

— Alena Kralikova

Sylwia Jaczynska-Kolasza, an Amgen employee based in Poland, was among the many who opened their doors to house refugees after the Russian invasion in mid-March. For her efforts, she said, simply: "All Poles help, not just me personally."

Kralikova decided to speak to her friend, who said he knew of six Ukrainians who needed shelter. Kralikova said she could provide them shelter in the farmhouse and he said he would drive to the Ukraine-Poland border to pick them up after they arrived from Kiev.

"He called me from the border and asked, 'Can you accommodate five more?'" Kralikova recalled. "I immediately said yes."

Farmhouse Comes Alive

Kralikova remembered when the 11 Ukrainians arrived at the farmhouse after a three-day trip from the Poland-Ukraine border in her friend's truck in the afternoon.

"I can never forget their faces when they arrived," she said. "They were shy. Totally lost. We cried together. I didn't know how to act, so I tried to open my arms and I only told them this is my house, but now it is your house and everything is yours."

There were two families that made up the 11, including six children who ranged in ages 6-17. She said they had fled Ukraine so quickly, they didn't have anything on them but their clothes. She went to the shop to get toothbrushes and other essential items. She got food. She made sure the beds had enough blankets. She picked up some toys for the kids, too.

Three of the 11 Ukrainians living in the farmhouse owned by Alena Kralikova after fleeing the war in their home country. Photo courtesy of Alena Kralikova.

Kralikova lives about a half-hour from the farmhouse and said she would go visit them a couple times a week to make sure they were doing OK. At first, she said, they were shy and reserved – and likely shocked from being displaced by the war. But, she said, as the weeks went by, they began to adapt.

She said they didn't talk much about the invasion or any horrors they may have seen. Kralikova spoke through two who spoke English and learned that they had husbands who were still in Ukraine. She said they were worried, but she didn't press them on details. Kralikova also discovered two of the women were pharmacists and, as fate would have it, there was a pharmacy with two openings.

A quick call led to quick interviews the same day. They were both hired. Kralikova said two of the women were teachers and another had been employed as a warehouse worker. The two teachers landed jobs at a maternity school that was helping refugees adapt. The warehouse worker secured a job as a house cleaner in Zlonin, just about 20 minutes outside of Prague.

She also made sure to get all the children enrolled in the local schools. Kralikova said the children started quickly and have been warmly received by their new classmates.

"It seemed important to get the children into as normal an environment as they could be," she said.

Kralikova said now that it's been several weeks since the families have been settling in, it's nice to see the farmhouse having a purpose again – its roof and walls providing sense of safety and shelter she remembered it providing when she was growing up there.

When she goes to visit them to see how they're doing, she said, they have settled into some routines that wouldn't have been fathomable just a few months ago.

On those visits, Kralikova said she still thinks of her dad coming in from the wheat fields after riding the tractor all day and preparing the crops for eventual sale. She said she remembered how some nights they'd eat around the table, laughing and telling stories and eating traditional meals – heavy on potatoes, onions and meat dishes.

"I still miss my father when I'm there and when the house was totally empty, I felt more sad in it," Kralikova said. "And now there are 11 people there and it's a lot. And I see them cooking in there and talking and I smile because in the farmhouse, there is life again."

Alena Kralikova's father harvesting grain on their farm outside of Prague in 2017. Photo courtesy of Alena Kralikova

Three Things to Know About the U.S. Marketplace with Biosimilars

Tue, 19 Jul 2022 18:12:47 Z

As part of Amgen's commitment to championing biosimilar education, we have released a preview of our 2022 Trends in Biosimilars Report, which examines the current state of biosimilars in the U.S. marketplace. Key findings confirm that it is a pivotal time for the U.S. marketplace with biosimilars. Biosimilar competition appears to be contributing to decreased drug spending, generating an estimated $18 billion in savings to the healthcare system for drug classes with biosimilar competition over the past six years. Further, the U.S. is poised to see growth in biosimilar approvals, similar to pre-pandemic rates, spurring additional competition that will potentially lead to significant savings for the healthcare system, which can then be deployed to newer, innovative treatments.

Jen Norton, Vice President, U.S. Value and Access at Amgen

Here's a closer look at three trends driving the U.S. marketplace with biosimilars.

1. Biosimilars are playing an important role in promoting a resilient U.S. healthcare system

Innovative medicines coupled with robust competition offer our best hope to effectively manage disease and contain long-term health care costs. To help build health system resilience, Amgen has committed to developing new innovative biologics as well as high-quality biosimilars that contribute to competition and provide additional treatment options.

It's crucial for the marketplace with biosimilars to remain strong and sustainable. The successful adoption of biosimilars has increased competition and generally lowered treatment costs associated with biologic medicines.

— Ian Thompson, Senior Vice President, U.S. Business Operations at Amgen

Since the first biosimilar launched in the U.S. marketplace in 2015, 36 biosimilars have been approved by the FDA and 22 biosimilars have been launched, providing patients, physicians and payers with a range of treatment options and a greater degree of flexibility of choice.^1,2

Key findings confirm that biosimilar competition may lead to cost savings for the healthcare system across both reference products and other biosimilars in the same therapeutic category. In fact, biosimilar prices have been decreasing at a compound annual growth rate (CAGR) of 9% to 22%, while prices of most reference products have been decreasing at a CAGR of 4% to 20%.³

2. Biosimilars are continuing to expand into new areas

Over the next few years, the growing number of biosimilars will likely lead to an evolution in the U.S. marketplace with biosimilars. We expect to see several advancements, including further expansion of biosimilars into pharmacy benefit reimbursement, launches in more therapeutic areas and approval of additional interchangeable biosimilars.

By 2023, it's estimated that competition in the U.S. marketplace with biosimilars will be nearly three times greater than it is today — with the potential to deliver billions in savings to patients, purchasers and insurers as the prices of reference products and biosimilars continue to decline. ⁴

Amgen is focused on addressing high-spend therapeutic categories, with two oncology biosimilars available in the U.S. market today, as well as two inflammation biosimilars. Building on our commitment to serve patients, we're excited to launch more biosimilars in the U.S., including AMJEVITA (our biosimilar to HUMIRA) in 2023, while developing other biosimilars that we hope will soon follow.

— Kave Niksefat, General Manager, Inflammation Business Unit at Amgen

3. Education is critical in cementing the role of biosimilars as viable and integral treatment options

As biosimilars continue to expand into new therapeutic areas, they will find new audiences in different prescriber specialties, and with pharmacists, payers and patients. With this, scientifically accurate educational outreach continues to be critical to support familiarity and confidence among providers and patients.

Biosimilars can be a complicated topic, making it challenging to foster trust in them among patients and prescribers. As we're seeing growth in the number of biosimilars, the time to dispel myths and drill down on science-based education is now.

— Leah Christl, Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen

Essential components of provider and patient use of biosimilars include payer coverage, as well as addressing clinical, operational and economic considerations to help support adoption.

Download a preview of Amgen's 2022 Trends in Biosimilars Report to learn more about how the contributions to competition made by biosimilars is contributing to a more resilient healthcare system, and look out for the full report in September 2022.

References

US Food and Drug Administration. Biosimilar product information. Updated May 26, 2022. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed May 2022.
Xcenda. Biosimilar approval and launch status in US. April 2022. Accessed April 26, 2022. https://www.xcenda.com/biosimilars-trends-report
Data on file, Amgen; [1]; 2022.
IQVIA Institute for Human Data Science. The Global Use of Medicine in 2019 and Outlook to 2023. January 29, 2019. Accessed May 2022. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.

Amgen Named a Best Employer for Women

Tue, 09 Aug 2022 22:14:09 Z

For the second year in a row, Amgen has been named one of the “Best Employers for Women” by Forbes, a leading business publication. This is the fourth Forbes list that Amgen has appeared on this year, having already been named one of “America’s Best Large Employers,” one of the “Best Employers for Diversity,” and one of the “Best Employers for New Grads.”

In compiling its latest list, Forbes partnered with the market research firm Statista to survey 50,000 Americans—30,000 women and 20,000 men—working for businesses with at least 1,000 employees. All respondents were asked to rate their organizations on criteria such as working conditions, diversity, and how likely they’d be to recommend their employer to others. Female respondents were also asked to rate their employers on factors such as parental leave, discrimination and pay equity. Representation at the executive and board levels were also factored into the final score.

Earlier this year on Mother’s Day, Amgen highlighted five working moms and the many different ways the company is supporting them, from child care to college coaching to maternity leave.

Amgen ranked #144 out of the 500 companies that made the list, up 100 spots from last year.

While the pandemic has led many women to downshift their careers or leave the workforce entirely, the percentage of females in Amgen’s global workforce has held steady for the past several years at 52%. Furthermore, the company’s efforts to increase the percentage of women in leadership roles is yielding positive results, with an 8% increase in representation at the executive director level and above in the past year and a 4% increase in representation at the senior manager/director levels. Women make up nearly 40% of Amgen’s Operating Team, which is comprised of the company’s senior-most leaders.

“We’re delighted to be ranked as one of the best employers for women,” says Tamika Jean-Baptiste, Amgen’s Chief Diversity Officer. “We continue to look for new ways to support our female staff, both professionally and in their personal lives.”

One tremendous source of ongoing support is Amgen’s “Women Empowered to Be Exceptional” employee resource group, better known as WE2, which now has 25 chapters in 20 countries and more than 4,300 members, up over 10% from last year as more staff join from outside the U.S.

“As a working mother myself, I’m not surprised to see Amgen make this list,” says Nada Obeid, an executive director on the company’s U.S. Value and Access team and the Global Chair of WE2. “The past few years haven’t been easy and the company has made a concerted effort to do whatever it can to support staff so they maximize their impact at work. It’s much appreciated.”

Click here for a full list of the many awards and accolades that Amgen has earned this year.

Amgen Recognized as Best Places to Work for Disability Inclusion

Amgen is deeply committed to creating diverse and inclusive environments where all staff feel a sense of belonging and purpose, and recent national recognition reaffirms that our efforts are making a difference. In addition to being named on the Forbes list of "Best Employers for Women," Amgen was also recognized as a Diversity Equality Index (DEI) "Best Places to Work for Disability Inclusion" by Disability: IN and the American Association of People with Disabilities.

“Amgen earning a top score in every DEI category is a testament to how much we truly value the contributions of all of our employees and the impact ERGs like Ability Bettered Through Leadership and Education (ABLE) can have on ensuring employees feel supported and safe in the workplace,” said Noemi Romero, vice president of Supply Chain and Global Chair of ABLE.

With more than 700 global ABLE members, support comes from all levels, including leadership and staff without disabilities. “ABLE is a tremendous resource for any employee seeking to understand, accept and overcome adversity,” said Peter Griffith, executive vice president, Chief Financial Officer and Executive Sponsor of ABLE. “The pandemic magnified the need for companies to invest in the physical, emotional and mental well-being of employees, and Amgen is proud to be recognized for our work in these areas.”

Biotech Takes Center Stage at Deutsches Museum

Wed, 10 Aug 2022 17:57:18 Z

The newly redesigned Amgen exhibit on biotechnology recently opened to the public at the Deutsches Museum (German Museum) in Munich, Germany. The Deutsches Museum is one of the world’s largest museums of science and technology, and Amgen has had a long-standing relationship with the museum, with the Amgen permanent exhibit first going on display in 2009. Following recent reconstruction of the museum, the Amgen exhibit is now located at the main entrance – so all visitors, 1 million annually, are welcomed by Amgen’s modules.

Nearly 30 Amgen employees from Amgen’s two sites in Germany (both recently featured in the Places of Amgen series on Instagram) assisted in designing the new exhibition materials, which include interactive videos, animations, models and graphics that illustrate how biotechnological medicines are created and how they can fight serious diseases.

The first stop in the exhibit explains the difference between chemically synthesized drugs and biopharmaceuticals. The complex manufacturing processes of biopharmaceuticals, a key distinguishing feature, are also presented in a way that is easy to understand.

The first stop in the exhibit explains the difference between chemically synthesized drugs and biopharmaceuticals.

Amgen’s innovative BiTE^® (bispecific T‑cell engager) technology is front and center, illustrated using models, a graphic novel and other animations. These anti-cancer immunotherapies have been developed by the team at Amgen Research (Munich) GmbH, and the exhibit shows how BiTE^® molecules activate the body's own T cells in the fight against cancer.

Amgen’s innovative BiTE^® (bispecific T‑cell engager) technology is front and center, illustrated using models, a graphic novel and other animations.

"We are very pleased to make the possibilities of medical biotechnology tangible with our immuno-oncological approach," explains Peter Kufer, managing director of Amgen Research Munich GmbH and developer of the BiTE^® technology. "The BiTE^® technology is also a great example of innovation 'Made in Germany'."

In addition, one video installation models a three-dimensional cross-section of an artery, showing how cholesterol impacts the body, while another interactive component is called “Insight Bone” because it shows the viewer’s movements mirrored by a skeleton to highlight the effect that osteoporosis may have on a patient’s life.

"As a pioneer in biotechnology, it is important to us to inform the general public about our innovative technology and its potential in medicine," says Manfred Heinzer, managing director of Amgen GmbH. “A survey that we carried out last year indicates a major gap in knowledge among the population: 97% of those surveyed have no idea what the term ‘biopharmaceuticals’ means. The Deutsches Museum exhibition is a great chance to show how biopharmaceuticals work and benefit people, and to share the wonder of biotechnology.”

Amgen Chronicles: Fresh Water and Fresher Ideas About Sustainability in Puerto Rico

Tue, 16 Aug 2022 15:13:17 Z

As an engineering student, Laura Vélez knew she wanted to work with utilities, using design to solve environmental challenges. Starting as an intern, and then becoming an associate engineer, for Facilities and Engineering at Amgen Manufacturing Limited (AML), in Juncos, Puerto Rico, she got the opportunity to learn the ins and outs of the highly complex processes used to treat wastewater from biopharmaceutical manufacturing.

“On the manufacturing side, there are all these utilities being used, but they don’t necessarily see all the work that goes on behind the scenes,” Vélez says. “I get to see a lot of what we do and how we distribute water, how we treat it, and all the complications that could have.”

Biopharmaceutical manufacturing relies on a never-ending flow of water to produce a consistent supply of medicines for patients. As sustainability and efficiency become increasingly important today Amgen has also made bold environmental commitments, including setting goals to become carbon neutral by 2027 and to reduce the company’s total water consumption by at least 40%.

Laura Vélez, associate engineer for Facilities and Engineering, is part of a team of sustainability-focused engineers innovating ways to clean and reuse water at Amgen’s largest manufacturing faciilty.

The Juncos site is Amgen’s largest biomanufacturing facility, which means it’s also the largest user of water, requiring around 450,000 gallons per day for its operations. That demand drove the site to become a hub of innovation where engineers like Vélez work continually to refine the processes for treating large amounts of wastewater, while also engineering new ways to reuse and significantly improve the overall efficiency of the site’s water use.

The path to becoming a leader in wastewater treatment for biotech

“Amgen’s Puerto Rico manufacturing facility had no on-site wastewater treatment capabilities 16 years ago,” explains José Martínez, senior manager of Environmental Health, Safety & Sustainability at Amgen’s Juncos facility. “Municipal water was taken in each day, and after one use, it was pumped into a fleet of 15 tanker trucks to be transported to local government facilities for treatment.”

As products and regulations changed, it became clear that the facility needed a way to treat wastewater on-site. “When it was decided to build a wastewater treatment plant, we said it needed to be a state-of-the-art system to ensure that it would continue serving our needs long into the future,” Martínez adds.

Today, this area of operations is not only focused on treating wastewater from biomanufacturing processes, but also on recapturing and reusing water from throughout the facility, to reduce usage everywhere, from the bioreactors to the restrooms and the outdoor landscaping.

The wastewater treatment plant occupies building 12 at Amgen’s sprawling manufacturing facility in Juncos, Puerto Rico, helping ensure more sustainable operations and continuous supply of medicines for patients.

“On the wastewater side, the biggest challenge is that we’re maintaining a living system, called an activated sludge system,” Vélez says. “It’s a huge colony of bacteria that treats the water, so we need to feed it well, and make sure it stays at the right temperature, and has the right amount of oxygen to breathe—it's almost like taking care of a child.”

This activated sludge process has become standard for wastewater treatment today. Still, one unique aspect of Amgen's Puerto Rico system is how the water gets filtered. “We use a more expensive and more advanced technology called membrane bioreactors,” Vélez says. “Most wastewater treatment plants just use simple settling tanks, which require a lot of space and time but cost less to operate. By filtering through a membrane, we can clean the same amount of water faster, and with a much smaller footprint.”

The entire site in Puerto Rico is designed to use as much as 500,000 gallons per day, but it currently uses around 450,000 gallons per day. “Of that total water, 25% ends up as a waste brine that must be cleaned and sent to the sewer, so a little more than 100,000 gallons goes to the sewer as clean water, which means we're not introducing additional waste into the island’s water treatment system,” says Juan Javier Díaz Cosme, senior manager, Maintenance, for the wastewater treatment plant in Puerto Rico. “The remaining water, approximately 337,000 gallons per day, is reusable. The result is nearly 250,000 gallons of water daily that we’re no longer buying or bringing from outside.”

A long history of compliance and recognition for sustainability efforts

For companies like Amgen, the operation of manufacturing facilities comes with regulatory oversight from U.S. government and local Puerto Rican environmental protection agencies. These important agencies monitor things like waste and emissions coming from manufacturing facilities. Since it was first created 15 years ago, the wastewater treatment plant at the Juncos facility has maintained a perfect record of compliance.

“We've never had a notice of violation, and we’re committed to operating wastewater treatment in compliance with regulations,” says Judith Velázquez, executive director of Engineering Services for Amgen in Puerto Rico. “We have a responsibility as Amgen to operate according to our values.”

Recently, Vélez attended a sustainability summit held by the Puerto Rico Manufacturers Association as a representative for her Facilities and Engineering function. At the event, Amgen was awarded gold-level recognition for its sustainability efforts in the categories of water conservation and sanitary waste. “Water conservation is one of the hardest things to do when your product is mostly made with water,” Vélez says. “Being there to represent Amgen was one of my biggest highlights.”

Workers at Amgen's Juncos facility perform system maintenance on the wastewater treatment plant.

Looking to an even more sustainable future

Amgen’s wastewater team in Puerto Rico has kept their facility on the cutting edge, but they aren’t resting on their laurels. Their ambitious goals for the future are to continue finding new ways to reuse water and driving toward an even more efficient system.

“We currently reuse around 50-60% of our water—compared to other companies, that’s a lot,” Martínez says. “At today’s level of sophistication there will always be some amount of water that can’t be reused after treatment, but we’re continuing to look for ways to close that gap and reuse as much as possible, including in places like utilities, cleaning the buildings’ roofs and outdoor areas, and in landscaping and firefighting activities.”

They’re also looking for other ways to reduce waste, such as converting the solid byproducts from wastewater treatment into nutrient-rich compost.

“Designing water systems with sustainability in mind is something we're going to have to work on continually,” Vélez says. “Doing this work creates value for the company, of course, but it’s about more than just us—it’s also about improving the world we live in. We don't have the same resources that we had 50 years ago. That's why I'm really passionate about water.”

How Amgen Is Propelling Precision Medicine Forward

Thu, 18 Aug 2022 15:24:01 Z

Earlier this summer, Jean-Charles Soria, senior vice president and head of Amgen's Oncology Therapeutic Area, and David Raben, vice president of Global Development, sat down for a Twitter Spaces live conversation on the impact of precision medicine in oncology, reflecting on recent successes and highlighting Amgen's research pursuing emerging actionable targets.

Over the past few decades, tremendous strides in genomics, proteomics and transcriptomics have enabled precision medicine to emerge as a new way of treating and customizing care for patients, accounting for more than a third of new drug approvals for four of the last five years. What makes precision medicine so meaningful and exciting as an approach is its potential to deliver improved outcomes for patients, while also minimizing toxicity given the specific responses these medicines mediate.

— David Raben, Vice President, Global Development

Listen to the full conversation below to hear their perspectives, and be sure to follow Amgen Oncology on Twitter to catch upcoming Twitter Spaces conversations.

How Genetic Validation Helped Innovate Medicine for Patients with High Cholesterol

Thu, 01 Sep 2022 22:13:34 Z

For people who have suffered a heart attack or other cardiovascular events correlated with high levels of LDL cholesterol, the development of PCSK9-inhibiting medicines has been one of the most exciting advances in cardiovascular medicine in recent years. At the European Society of Cardiology Conference in Barcelona at the end of August 2022, Amgen announced the full data from its completed FOURIER-OLE study of its first-in-class PCSK9 inhibitor Repatha (evolocumab), making it the longest data set for any biologic medicine approved for patients with cardiovascular disease to help reduce the risk of cardiovascular events, like heart attack and stroke, by meaningfully and sustainably reducing a patient’s LDL-C.¹ Here’s the backstory on how this innovation unfolded.

Repatha^® is indicated:
In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization

IMPORTANT SAFETY INFORMATION

Please see additional Important Safety Information at the end of this article.

Cardiovascular disease and lowering bad cholesterol: The journey

PCSK9 inhibitors were among the first medicines developed through a relatively new process called genetic validation, in which scientists identify a genetic target in humans associated with a disease, leading to the development of a medicine that will interact with that target to achieve a specific health goal.²

It was important to apply the most precise tools available to reducing cholesterol because high cholesterol (specifically high LDL cholesterol, or LDL-C) is among the most well-established risk factors for cardiovascular disease, the leading cause of morbidity worldwide.^3,4 Globally, the prevalence of cardiovascular disease cases doubled from 271 million in 1990 to 523 million in 2019.⁵

Prior to the development of PCSK9 inhibitors, statins and ezetimibe were the only effective medicines available to help lower LDL-C⁶. However, not all patients are able to achieve sufficiently low LDL levels with statins and ezetimibe.²

From genetic insight to investigational medicine

The path to bringing PCSK9 inhibitors to patients began with scientists in France who were studying multiple generations of a single family that exhibited unusually high levels of LDL-C.⁷ In the journal Nature Genetics, the scientists proposed that the family’s history of heart disease and high LDL-C was correlated with a particular mutation in a gene called proprotein convertase subtilisin/kexin type 9 (PCSK9).⁷

Independently, a group of researchers from Dallas Heart Study found that different mutations of PCSK9 could be correlated with lower LDL-C.⁸ “That showed both sides of the penny had been proven,” says Simon Jackson, Amgen’s executive director of research for Cardiometabolic Disorders. “By 2006, they found that people with these variants were less likely to develop cardiovascular disease.”⁸

Capturing this insight was incredibly meaningful but scientists were still a long way off from taking this insight and turning it into a cholesterol-lowering medicine.

Amgen’s own PCSK9 research program began in 2005, and the scientists on Jackson’s team were able to identify how these variants in the PCSK9 gene were impacting cholesterol levels. They discovered that PCSK9 binds directly to LDL receptors on the liver, which results in the breakdown of the LDL receptor. This prevents the liver from clearing LDL-C from the blood. Once this was understood, Amgen’s efforts focused on ways to inhibit PCSK9 protein binding to LDL receptors, so that LDL-C clearance by the liver could be increased.

“We showed that the PCSK9 protein and the LDL receptor protein came together,” Jackson explains. “That launched the whole idea of creating an antibody that would bind PCSK9 circulating in the blood, and therefore stop it from binding to the LDL receptor.” Jackson’s team accomplished this through a process called immunoprecipitation, a technique for isolating a protein antigen out of a solution, along with any proteins bound to it.

“That was the 'aha' moment for our team, leading to the hypothesis that an antibody that binds PCSK9 might be useful as a therapeutic. We launched our antibody program in 2006,” Jackson says. “We did our first proof of concept in 2007, showing for the first time that our antibody candidate could lower cholesterol levels, and at the end of 2007, we nominated AMG 145 as the clinical candidate.”

Bringing first-in-class medicine to patients

First-in-human trials for AMG 145 started in 2009.⁹ Subsequent trials showed AMG 145 significantly reduced LDL-C among at-risk subjects and demonstrated a consistent safety profile.¹⁰ By 2013, Amgen launched the cardiovascular outcomes study, Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER).¹¹

In the following year, the U.S. Food and Drug Administration (FDA) had accepted Amgen's Biologics License Application (BLA) for the medicine, now called Repatha.¹² Over the next two years, Repatha earned several global approvals, becoming the first PCSK9 inhibitor available to help reduce LDL-C in at-risk patients:¹³

July 21, 2015: The European Commission approved Repatha as a treatment of patients with uncontrolled cholesterol who require additional intensive LDL-C reduction¹⁴
August 27, 2015: FDA approved Repatha to treat patients with high cholesterol¹⁵
September 10, 2015: Health Canada approves Repatha¹⁶
January 21, 2016: The Japanese Ministry of Health, Labour and Welfare approved Repatha as the first PCSK9 inhibitor in Japan¹⁷
July 11, 2016: FDA approves Repatha Pushtronex as the first and only single monthly injection for a PCSK9 inhibitor¹⁸

The FOURIER trial was completed in November 2016 and demonstrated that patients with cardiovascular disease treated with Repatha had a significant reduction in major cardiovascular events like heart attack and stroke.¹⁹

“Amgen continued to study the long-term safety of Repatha among FOURIER trial subjects by launching two extension studies (FOURIER OLE) that enabled patients completing FOURIER to receive Repatha for up to five years,” explains Narimon Honarpour, vice president of Global Development for Amgen’s General Medicine therapeutic area.¹

The FOURIER-OLE trial started in March 2017 and completed in February 2022—results will be presented at the 2022 ESC conference.²⁰ Completed and ongoing Repatha studies make Amgen’s research the longest-running data set for any PCSK9 inhibitor currently available to patients.¹

Amgen has continued to expand the treatment paradigm for Repatha, with the FDA approving Repatha for pediatric patients aged 10 years and older with familial hypercholesterolemia, an inherited disorder that results in extremely high cholesterol starting at birth.²¹

“Today, Amgen is dedicated to improving the lives of patients with cardiovascular disease. Since launch, more than 1 million patients worldwide have received Repatha to reduce LDL-C,” Honarpour says.²² “However, cardiovascular disease remains the leading cause of morbidity worldwide.²³ This is partly because there are additional risks beyond LDL-C that contribute to cardiovascular illness.²³ Addressing the remaining risk is an important motivator for Amgen in its mission to serve patients with serious unmet medical need.”

INDICATIONS

Repatha^® is indicated:

In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization
As an adjunct to diet, alone or in combination with other low-density lipoprotein cholesterol (LDLC)-lowering therapies, in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C
As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients aged 10 years and older with HeFH, to reduce LDL-C
As an adjunct to other LDL-C-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C

The safety and effectiveness of Repatha^® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hyperlipidemia.

IMPORTANT SAFETY INFORMATION

Contraindication: Repatha^® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha^®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha^®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha^®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha^®, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions in Adults with Primary Hyperlipidemia: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha^®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha^®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha^® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the Cardiovascular Outcomes Trial: The most common adverse reactions (>5%of patients treated with Repatha^® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha^®, 8.2% placebo), nasopharyngitis (7.8% Repatha^®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha^®, 4.8% placebo).

Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha^® compared with 7.7% in patients that received placebo.
Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha^® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha^® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
Immunogenicity: Repatha^® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha^®.

Please see full Prescribing Information.

References:

O'Donoghue, Michelle (2022, August 26-29). FOURIER-OLE Primary Results [Conference Presentation]. European Society of Cardiology Convention, Barcelona, Spain.
Kamb, A., Harper, S., & Stefansson, K. (2013). Human genetics as a foundation for innovative drug development. Nature biotechnology, 31(11), 975–978. https://doi.org/10.1038/nbt.2732.
Goldstein JL, et al. Arterioscler Thromb Vasc Biol. 2009;29(4):431-438.
World Health Organization. Cardiovascular diseases (CVDs) fact sheet. http://www.who.int/mediacentre/factsheets/fs317/en/. Accessed August 2022.
Roth, Gregory A et al. “Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study.” Journal of the American College of Cardiology vol. 76,25 (2020): 2982-3021. doi:10.1016/j.jacc.2020.11.010.
Chaudhary, R., Garg, J., Shah, N., & Sumner, A. (2017). PCSK9 inhibitors: A new era of lipid lowering therapy. World journal of cardiology, 9(2), 76–91. https://doi.org/10.4330/wjc.v9.i2.76.
Kolata, G. (2013, July 10). Rare mutation ignites race for cholesterol drug. The New York Times. Retrieved August 16, 2022, from https://www.nytimes.com/2013/07/10/health/rare-mutation-prompts-race-for-cholesterol-drug.html.
Pierson, R. (2011, August 26). Separate paths lead to promising cholesterol drug. Reuters. Retrieved August 25, 2022, from https://www.reuters.com/article/health-cholesterol-discovery/separate-paths-lead-to-promising-cholesterol-drug-idUSN1E77O1IE20110826
Data on File, Amgen; 2022.
Dias, C. S., Shaywitz, A. J., Wasserman, S. M., Smith, B. P., et. al. (2012). Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. Journal of the American College of Cardiology, 60(19), 1888–1898. https://doi.org/10.1016/j.jacc.2012.08.986.
Amgen. (2013, November 19). Amgen Announces Evolocumab (AMG 145) Results From First 52-Week Study Of A PCSK9 Inhibitor To Reduce LDL Cholesterol [Press Release]. Retrieved From https://www.amgen.com/newsroom/press-releases/2013/11/amgen-announces-evolocumab-amg-145-results-from-first-52week-study-of-a-pcsk9-inhibitor-to-reduce-ldl-cholesterol.
Amgen. (2014, November 10). FDA Accepts Amgen's Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab [Press Release]. Retrieved From https://www.amgen.com/newsroom/press-releases/2014/11/fda-accepts-amgens-biologics-license-application-for-ldl-cholesterollowering-medication-evolocumab.
Amgen. (2017, December 1) FDA Approves Amgen’s Repatha^® (evolocumab) To Prevent Heart Attack And Stroke [Press Release]. Retrieved from https://www.amgen.com/newsroom/press-releases/2017/12/fda-approves-amgens-repatha-evolocumab-to-prevent-heart-attack-and-stroke.
Amgen. (2015, July 21). Repatha™ (evolocumab) Now Approved in the EU [Press Release]. Retrieved From https://www.amgen.com/stories/2015/07/repatha-evolocumab-now-approved-in-the-eu.
Amgen. (2015, August 27). FDA Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab) [Press Release]. https://www.amgen.com/newsroom/press-releases/2015/08/fda-approves-amgens-new-cholesterollowering-medication-repatha-evolocumab.
Amgen Canada. (2015, September 15). Health Canada Approves Amgen's New Cholesterol-Lowering Medication Repatha (evolocumab) [Press Release]. https://www.biospace.com/article/releases/health-canada-approves-amgen-s-new-cholesterol-lowering-medication-repatha-evolocumab-/
Amgen. (2016, January 21). Amgen’s Repatha^® (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol [Press Release]. Retrieved From https://www.amgen.com/newsroom/press-releases/2016/01/amgens-repatha-evolocumab-approved-as-first-pcsk9-inhibitor-in-japan-for-the-treatment-of-high-cholesterol.
Amgen. (2016, July 11). FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor [Press Release]. Retrieved From https://www.amgen.com/newsroom/press-releases/2016/07/fda-approves-first-and-only-single-monthly-injection-for-a-pcsk9-inhibitor.
Amgen (2017, March 17). Landmark Outcomes Study Shows That Repatha^® (Evolocumab) Decreases LDL-C To Unprecedented Low Levels And Reduces Risk Of Cardiovascular Events With No New Safety Issues [Press Release]. https://www.amgen.com/newsroom/press-releases/2017/03/landmark-outcomes-study-shows-that-repatha-evolocumab-decreases-ldlc-to-unprecedented-low-levels-and-reduces-risk-of-cardiovascular-events-with-no-new-safety-issues.
Fourier open-label extension study in subjects with clinically evident cardiovascular disease in selected European countries - full text view. Full Text View - ClinicalTrials.gov. (n.d.). Retrieved August 29, 2022, from https://clinicaltrials.gov/ct2/show/NCT03080935.
Amgen. (2021, September 24). FDA Approves Repatha^® (evolocumab) In Pediatric Patients Age 10 And Older With Heterozygous Familial Hypercholesterolemia [Press Release]. Retrieved From https://www.amgen.com/newsroom/press-releases/2021/09/fda-approves-repatha-evolocumab-in-pediatric-patients-age-10-and-older-with-heterozygous-familial-hypercholesterolemia.
Data on File, Amgen; 2021.
World Health Organization. (n.d.). Cardiovascular diseases (cvds). World Health Organization. Retrieved August 29, 2022, from https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)#:~:text=Cardiovascular%20diseases%20(CVDs)%20are%20the,%2D%20and%20middle%2Dincome%20countries.

Wrapping Up Amgen’s “Summer of Science” Instagram Series

Mon, 29 Aug 2022 23:59:24 Z

Throughout the summer months, a handful of Amgen’s innovative and inspiring scientists shared what motivates them to serve patients through cutting-edge research as part of the “Summer of Science” series on Amgen’s Instagram page. Those who participated not only offered insights into the company's exciting biotechnology work, but they also shared powerful stories about what sparked their passions for science in the first place.

For Ryan Potts, the experience of being diagnosed with brain cancer at two years old turned into a lifelong passion for biomedical research, which led him to become head of Amgen’s Induced Proximity Platform. While Marissa Mock's childhood habit of conducting "amazing and foul kitchen experiments" helped lay the groundwork for her role as director of Generative Biology at Amgen, Mock also enjoys teaching others about her field, as evidenced by her appearance in one of Amgen’s inaugural videos on TikTok.

Click on the links below to read these stories.

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For those interested to dive deeper into the fascinating (yet complex) topic of Generative Biology, check out The Generative Biology Revolution, a four-episode Amgen podcast also released over the summer, hosted by Ray Deshaies, Amgen’s senior vice president of Global Research.

Amgen Origins: Post 9/11, Dora’s Legacy Endures Through Cancer Care

Fri, 09 Sep 2022 18:57:42 Z

The halls are mostly quiet, save for the occasional soft knock on a door before a doctor or nurse enters the room to check on a patient. In a few recessed pockets along the hallways, computers monitor the vitals of each private battle being waged against cancer.

Some doors are adorned with colorful signs; a green apple means a patient with low blood sugar while a yellow and black placard featuring a shooting star signifies the person is at risk for falling down. On the counter of the reception area is a small white swan fashioned out of paper. It was made by a patient.

Dr. John Glaspy has walked these hallways many times over the course of many years. The medical oncologist saw patients, met the families and friends providing support to the patients – mostly with leukemia – and he’s incredibly proud of the doctors and nurses who are bringing the fight to cancer with everything they’ve got every single day.

But when he would enter this particular quadrant of the Ronald Reagan UCLA Regional Medical Center, Glaspy always noticed the plaque on the side wall next to the reception window: In Memory of Ms. Dora Menchaca.

Dr. John Glaspy. Photo Courtesy of Ronald Reagan UCLA Medical Center.

She had been a good friend and scientific collaborator of his for several years.

His mind would then go back to Sept. 11, 2001 – the day the United States was attacked by terrorists. The day the World Trade Center came down before his disbelieving eyes. The day dark smoke billowed above the Pentagon like from some surreal movie. Before the day was done, four passenger planes had all been felled and left thousands dead in New York, Washington DC and Shanksville, Pennsylvania and left a nation numb.

Glaspy knew Menchaca was in the nation’s capital briefing the U.S. Food and Drug Administration on some cancer research the day before the attacks. But didn’t know a fateful decision she had made to take an earlier flight on the morning of Sept. 11 would mean neither he nor her family would ever see her again.

Menchaca boarded on American Airlines Flight 77 – one of the four planes that was hijacked on 9/11 – because she wanted to get home sooner to be with her husband and two children in California.

Glaspy couldn’t reach her on his phone all morning as he watched the shocking images on television. He spoke with mutual friends, who didn’t know her fate either. Eventually, however, the call came. The news he didn’t want to hear was heard. Menchaca was gone.

“I cried,” he said.

Keeping Her Memory Alive

The details are fuzzy to Glaspy, but the memories of how he felt 21 years ago after she died remain crystal clear.

He wanted to be involved in keeping Menchaca’s memory alive after 9/11. Coincidently, he had been meeting with top leaders at Amgen before the attacks. He said the company had expressed interest to him about making donations that would have a real impact on the world.

Glaspy mentioned the Ronald Reagan UCLA Regional Medical Center was being built because the old hospital had some damage due to the 1994 Nothridge earthquake. Money was, he said, still in the process of being raised to construct the new facility in Westwood.

After 9/11, Glaspy met with executives at Amgen and the idea took hold immediately – donate some money toward construction of the new hospital.

“The whole country was smarting from Sept. 11 and having a chance to do something positive in conjunction with this tragedy was a way to defiantly refuse to let your knees bend and to force evil to give way to something good,” Glaspy said.

Amgen donated $3 million toward the construction of the Ronald Reagan UCLA Medical Center, which was dedicated in 2007 as a state-of-the-art facility with 520 large private rooms for patients. As a part of that construction, an area of 26 private rooms for cancer patients – mostly with leukemia – was named in memory of Menchaca.

“Dora was a respected and beloved member of the Amgen family,” Amgen CEO Bob Bradway said. “We remember and miss her, but also take some comfort in knowing patients are being well cared for in a place that bears her name.”

For the last 15 years, Glaspy said thousands of patients have come through the quadrant of the hospital, receiving a variety of cancer treatments, including bone marrow transplants. He said there is a strong family dynamic in the ward, too, as many of the patients can be there long-term as they receive treatment.

He said there is also a sense of “esprit de corps” in the unit as people with cancer rally around each other and pull for each other. He said Menchaca, who always understood the importance of family, would appreciate the daily work that goes on there.

“She was a young mother and she was also an incredible, scientifically-gifted professional whose number one priority was her family,” Glaspy said. “But she also worked so hard. I remember talking to her at midnight, after her kid was in bed, and she could finish her 14 hours of work. She was dedicated to that level of scientific excellence.”

Dr. John Glaspy. Photo Courtesy of Ronald Reagan UCLA Medical Center.

On Her Shoulders

Menchaca was a director of clinical research with a focus on cancer – a drive that sprung from her own father’s diagnosis with prostate cancer.

She had multiple degrees, including a master’s degree in public health from the University of North Carolina and a doctorate in epidemiology from UCLA, which she completed in 1986. As the first member of her Mexican-American family to attend college, she sought to help others by volunteering at schools to encourage students of color to pursue STEM studies.

Her death on 9/11 shook everyone who knew her. When there was a tribute memorial for her at Amgen’s Thousand Oaks site, about 5,000 people showed up to honor her, according to a Los Angeles Daily News account.

“I felt like I’ve been run over by a Mack truck and haven’t gotten up yet,” Amgen employee Bill Sheridan said at the service.

And Kevin Sharer, Amgen’s chief executive officer at the time the donation was made, said at the memorial that Menchaca’s “passion and belief in doing whatever it takes to help patients and advance science will have a lasting impact.”

Glaspy went to the memorial and spoke as well. He told the crowd about how she was a professional woman who valued her family. But he also began to see how her scientific legacy was helping others to be with their families longer, too.

He said he remembered how the two of them worked on a clinical trial for a cancer drug that involved stem cell factor, a process that causes blood stem cells to change into different types of blood cells and increases the number and actions of these cells in the blood rather than harvesting it from bone marrow.

Glaspy said that while the drug didn’t make it to market in the United States, it produced information that they still use today in the ward for cancer patients.

“It’s not just her memory that lingers,” Glaspy said. “It’s also her contributions. I stop to think about it, whose shoulders we are standing on, when I see her name and the unit is full. It continues to serve patients and will be there much longer than I’m on earth and that is a powerful legacy.”

Dora's memory has been honored at Amgen with a reflection garden and marker at the company's global headquarters in Thousand Oaks, California. The inscription reads: "Dora Menchaca – scientist, mother, wife, colleague, friend. Much admired, greatly missed."

"Amgen Origins" is a series focused on highlighting the origin stories behind innovations large and small across Amgen.

Asthma Peak Week: What You Need to Know About Indoor Air Pollution

Tue, 13 Sep 2022 15:07:58 Z

The third week of September each year in the U.S. is known as Asthma Peak Week, the week that typically has the highest concentration of asthma flare ups and hospitalizations all year.¹ While Peak Week is a challenging time for people with respiratory conditions, like severe asthma, there are things people or their loved ones can do to help mitigate potential triggers this week and throughout the year. And, while you can’t always control what you’re exposed to outside, there are ways to manage items in your home to create a space that is more asthma and allergy friendly. So, for this Q&A we sat down with two experts who live with asthma themselves: Dr. Payel Gupta, a physician and asthma and allergy specialist, and Andrea J., a Certified Asthma Educator (AE-C), who works in public health, has asthma – and raised three children living with asthma.

Why is indoor air pollution a problem? What are some of the most common household allergens and triggers for asthma? Do they cause indoor air pollution?

Dr. Gupta: Most people spend the majority of their day indoors, and while we might be aware of, or be able to see, the visible signs of poor air quality outside, our indoor air quality is often overlooked and can be worse than the air outdoors if we’re not careful. While specific asthma triggers vary person to person, dust, dust mites, mold, cockroaches, mice, pets, viruses and VOCs (Volatile Organic Compounds, which come from things like burning candles, perfumes, cleaning products and cooking) are some of the most common triggers in a home for someone living with asthma. Outdoor pollutants can also enter the home, especially if you live near a busy roadway. If you feel there’s something in your environment triggering your asthma but aren’t sure what it is, you should ask your doctor about allergy testing to help pinpoint.

The third week of September each year in the U.S. is known as Asthma Peak Week. Why is this time of year challenging for people living with asthma, and how can they prepare for it?

Dr. Gupta: I often refer to Peak Week as “the perfect storm” because the reason this time of year can be so challenging is largely due to two separate factors. First, it’s peak ragweed season, which is not only a very common allergy but can trigger allergic asthma. Second is the Back-to-School timeframe. Kids are exposed to a lot of viruses and asthma triggers this time of year and are often bringing them home with them. Given the uptick in exposure, this is an opportune time to check-in on your or your child’s level of asthma control and see if any changes to either of your asthma management plans need to be made. A good rule of thumb to gauge if your asthma may be uncontrolled is the “Rules of Two”: having asthma symptoms or using a rescue inhaler more than two times per week, waking up at night with asthma symptoms two or more times per month, or refilling your rescue inhaler more than two times per year. If you’re experiencing any of the above, your asthma may not be well controlled, and you should discuss additional management options with an asthma specialist, such as an allergist or pulmonologist.^2,3

Andrea J.: In terms of preparation, it’s important to make sure you and your kids are up to date on your asthma management plans and have a non-expired rescue inhaler ahead of the school year. Kids can legally carry their inhaler in all states in the U.S. However, parents may need to have a “Self Administration Form” signed by them, their child’s doctor and the school nurse; so it’s important to contact your school ahead of time to confirm their policy. It’s also important to practice good hygiene. Make sure that you and your family are diligent with handwashing, and that you are blowing your nose when returning home from school or being outside of the house to clear out any allergens.

What can patients or caregivers do to keep their homes asthma friendly?

Andrea J.: Beyond regularly washing your bedding in hot water and using protective coverings — including on pillows! – to minimize dust mite reactions, air purifiers with HEPA filters are an incredibly important management tool in the home. Just like air conditioning units, it’s important to make sure that your air purifier is fit for the size of the space it’s in. For example, a large living room may require something different than a bedroom. An air purifier will help trap unwanted particles like dust, dander, pollen, mold and other common allergens that may trigger asthma. Another common source of indoor air pollution is what we track inside. During peak pollen seasons, even small changes like removing your shoes at the front door, changing your clothes and showering before bed can help prevent pollen and other allergens you picked up outside from sticking around. And if you’re traveling to visit friends or family, remember that it’s important to communicate your allergy and cleanliness needs ahead of time so they can help prepare your space. Your loved ones want you to feel well and might not be aware of the special precautions you need to take!

Dr. Gupta: Two things that are often the hardest for people to adapt to lifestyle-wise are pets and candles. We all love our pets and love our homes to smell nice, but both can be huge triggers for asthma flare-ups. With pets, you may be allergic to the pet themselves or allergic to the dust and allergens that get trapped in their fur. For either scenario, I recommend keeping pets out of bedrooms as much as possible and bathing them regularly, ideally once a week to minimize dander. For candles, I advise no candles or any product that puts scent into the air. To address household smells, proper air flow and air purifiers can help remove any unwanted scent from cooking you may want to cover up.

Any other surprising household triggers you’ve encountered?

Andrea J.: The kitchen and the bathroom are two spaces people often don’t think about. In both spaces, you often need to use more heavy-duty cleaning products to ensure surfaces are sanitized. Products that have strong fumes can trigger asthma, so wearing a mask can help minimize fume intake. In the bathroom, you also want to make sure you’re letting the space air out after showers that produce steam, as any trapped moisture can cause mold to grow. A dehumidifier can also be helpful for high humidity climates to prevent mold growth.

To close, what is your biggest piece of advice for anyone living with asthma or who may have a child with asthma?

Dr. Gupta: Make sure to check in with your doctor before your problems impact your day-to-day life. People often only seek treatment for their asthma when it becomes a problem and ignore symptoms that can be an indication of underlying inflammation. Addressing your asthma in a preventative way can help reduce exacerbations, visits to urgent care and the ER in the future.^4,5

Andrea J.: If you’re a parent to a child with asthma, trust your gut. If you sense something is off, don’t be afraid to advocate for your own and your families’ specific needs, and continue to seek the advice of a doctor or an asthma specialist. It’s also important to keep track of how often your child is using a rescue inhaler and the frequency of their symptoms. Knowing this will help you become an active participant in their care and help you to identify the signs that something isn’t normal for your child.

To learn more about how you can better understand and manage your asthma, sign up for live virtual events through LUMA (Learn to Understand and Manage Severe Asthma) by visiting https://luma-edu.com/. There will be two sessions dedicated to Peak Week on September 28, 2022 at 8pm PST and 8pm EST.

References:

Services, AAFA Community. “Brace Yourselves: The Biggest Week for Asthma Attacks Is Coming.” Asthma and Allergy Foundation of America, https://community.aafa.org/blog/September-Asthma-Peak-brace-yourselves-the-biggest-week-for-asthma-attacks-is-coming. Accessed August 2022
“Severe Asthma.” American Lung Association, https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/learn-about-asthma/severe-asthma. Accessed August 2022
“Assess and Monitor Your Asthma Control.” American Lung Association, https://www.lung.org/lung-health-diseases/lung-disease-lookup/asthma/living-with-asthma/managing-asthma/assess-and-monitor-your. Accessed August 2022
“Asthma Facts and Figures.” Asthma and Allergy Foundation of America, https://www.aafa.org/asthma-facts/#:~:text=On%20average%2C%2011%20people%20in,the%20right%20treatment%20and%20care.&text=In%202020%2C%20deaths%20due%20to,first%20time%20in%2020%20years. Accessed August 2022
“FastStats - Asthma.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 1 Feb. 2022, https://www.cdc.gov/nchs/fastats/asthma.htm. Accessed August 2022

Celebrating Hispanic Heritage Month

Tue, 13 Sep 2022 20:51:17 Z

Amgen is proud to recognize Hispanic Heritage Month and the incredible impact and contributions of the diverse Hispanic cultures to the United States. We celebrate the heritage, history and achievements of Hispanics and the many distinct and dynamic perspectives our colleagues bring to the workplace and society.

Read more about the experiences of our Latino and Hispanic colleagues as well as our Diversity, Inclusion and Belonging efforts at Amgen.

Candid Conversations: Amgen Latin Employee Network

This video features a transparent dialogue between Esteban Santos, executive vice president, Operations, executive sponsor of Amgen Latin Employee Network (ALEN) and Kristyna Rodriguez Powell, director of Global Accounting, global chair of ALEN.

Diversity, Inclusion and Belonging at Amgen

What’s Next at #ESMO22

Fri, 09 Sep 2022 12:59:56 Z

The European Society for Medical Oncology Congress 2022 (ESMO) has officially kicked off in Paris. Each year, ESMO convenes some of the world's most influential oncology experts to discuss the latest advances in cancer care.

What's Next at ESMO 2022

Key data from Amgen's global KRAS^G12C inhibitor development program will be presented at ESMO, including detailed confirmatory data from the first randomized, controlled Phase 3 clinical trial of a KRAS^G12C inhibitor in non-small cell lung cancer.

New combination data from the CodeBreaK 101 study in patients with KRAS G12C-mutated colorectal cancer (CRC) will also be presented. KRAS is a commonly mutated oncogene in CRC, with mutations in approximately 40% of all cases, with the KRAS G12C mutation present in approximately 3-5% of colorectal cancers. These patients have a dismal prognosis and have very limited treatment options.

Optimizing Biomarker Testing

A critical component to KRAS treatment remains optimizing biomarker testing for patients. Leading up to ESMO, Amgen leaders Jean-Charles Soria, senior vice president and head of Amgen's Oncology Therapeutic Area, I-Fen Chang, vice president of Oncology Late Development, and David Raben, vice president of Oncology Global Development, spoke with special guest Dr. Kashyap Patel, president of the Community Oncology Alliance, to discuss new innovations in thoracic oncology.

The group also talked about Amgen's work in collaboration with organizations like the Community Oncology Alliance to expand biomarker testing and ensure results are leveraged to inform treatment throughout a patient's journey.

Listen to the full Twitter Spaces conversation below.

Be sure to follow Amgen Oncology on Twitter for real-time updates throughout ESMO, and follow the event hashtag on Twitter #ESMO22 for the latest congress news.

Listen in to Innovating Clinical Trials, the Next Amgen R&D Serial Podcast

Thu, 01 Sep 2022 15:36:33 Z

Amgen's R&D next podcast series Innovating Clinical Trials is now available wherever you listen to podcasts. Produced in partnership with The Scientist, Innovating Clinical Trials explores the latest in clinical trial design and execution, including real-world examples of how researchers in our industry can run trials better and faster to develop optimal medicines that benefit more patients.

Because clinical trials are complex and multidisciplinary, there is not a single, simple solution. What does innovation in clinical trials look like? In this series, host Rob Lenz, M.D., Ph.D, Amgen's senior vice president of Global Development, and experts leading next-generation clinical trials explore trends and drivers in design and execution to improve trial quality and safety, decrease costs, and improve predictability, reliability, and speed.

"Our understanding of human biology and disease is progressing at an unprecedented pace, and clinical trial development and execution needs to evolve just as quickly to deliver potentially lifesaving medicines to patients who can't wait," said Lenz. "Indeed, innovation within clinical trials is accelerating like never before. The new podcast series, Innovating Clinical Trials, gives an inside view of how the industry can bring trials closer to patients and include broader representation of patients likely to benefit from new medicines."

The first episode launches Sept. 1, and the series continues with a new episode every Thursday through Sept. 22. You can find Innovating Clinical Trials here or by subscribing to The Scientist's series LabTalk on Apple Podcasts, Spotify, Stitcher, Google Podcasts, or wherever you like to listen.

September 1: Operational Innovation
Dr. Cynthia Verst, President, Design and Delivery Innovation, R&D Solutions at IQVIA

September 9: Real-World Data in Drug Development
Brian D. Bradbury, D.Sc., Vice President, Center for Observational Research at Amgen

September 16: The Right Patients
Dr. Ponda Motsepe-Ditshego, Vice President and Therapeutic Area Head of Global Medical, General Medicine at Amgen

September 23: Real-World Clinical Trial Design and Execution in Oncology
David Raben, M.D., Vice President Global Development & Product General Manager, Oncology at Amgen

In addition to the podcast series, Amgen and The Scientist will offer a live webinar with Taras Carpiac, executive director of clinical trial process improvement at Amgen, to dig deeper into the latest trends in clinical trial design and execution. Register to listen here.

Innovating Clinical Trials is the fourth podcast series Amgen is hosting in partnership with The Scientist. You can find the first three series, DNA Unlocked, Undruggable and Generative Biology Revolution, here.

Amgen Is Ready to Meet Growing Demand for Innovative Medicines, Says Bradway in Bloomberg TV Interview

Fri, 16 Sep 2022 21:06:58 Z

Speaking with Bloomberg TV from Amgen's newest manufacturing facility in West Greenwich, Rhode Island, Amgen CEO Bob Bradway said the plant has set a new standard for efficiency and environmental sustainability and will enable Amgen to meet growing demand for its medicines, many of which treat serious and widespread chronic diseases. He warned, though, that recent U.S. drug price control legislation threatens to discourage biopharmaceutical innovation just when it is most needed. Bradway spoke on September 14 with "Bloomberg: Market Close" co-anchors Caroline Hyde and Taylor Riggs.

Bradway remarked that the new Rhode Island facility expands Amgen's ability to manufacture protein-based medicines "at an improved cost and improved efficiency in a shorter timeframe than any other facility in the world." He emphasized the plant's environmental sustainability, noting that "we have been able to shrink the footprint by some 75 percent and dramatically decrease the amount of energy and water we consume and the amount of waste we produce."

The Rhode Island facility, together with two other state-of-the-art manufacturing plants currently under construction in Ohio and North Carolina, represents a $1 billion investment that will permit Amgen to meet growing demand for our medicines aimed at serious and prevalent conditions such as cancer and cardiovascular disease. "We have been very focused on investing in the science and technology of biomanufacturing, which is enabling us to produce medicines more effectively and reliably," Bradway commented. "As the demand for what we are doing continues to increase, we need to be able to keep pace and be in a position to supply every patient every time—something we are proud to have done throughout our 42-year history."

While COVID has understandably dominated attention over the past three years, Bradway observed that chronic conditions such as cancer, heart disease, and osteoporosis have not gone away—in fact, their prevalence has increased as many people at risk of these conditions did not obtain timely diagnosis or treatment due to COVID. "Now those people are showing up with their diseases at a more advanced state," which makes it harder to treat them successfully. Thankfully, Bob added, we have the means to predict who is at highest risk of cancer, heart disease, and osteoporosis, and to prevent many such people from falling ill. "The earlier we can start treatment for these conditions," he concluded, "the better we are able to prevent the downstream consequences."

Amgen stands ready to provide the innovation needed to help patients manage these chronic conditions, thanks to its broad portfolio of marketed medicines and its robust pipeline of potential new treatments. Bradway emphasized that Amgen's innovation comes in roughly equal parts from its own laboratories and from external alliances and acquisitions. Recent home-grown innovations include LUMAKRAS^® and TEZSPIRE^®. The company also scans the external landscape for "therapies that are innovative, first-in-class medicines making a big difference for patients where the unmet medical need is high." Amgen's recently announced acquisition of ChemoCentryx, for instance, brings with it TAVNEOS^®, which Bob noted is a first-in-class innovation for a serious autoimmune disease.

Unfortunately, the new U.S. Inflation Reduction Act—which would impose government price controls on certain medicines provided through Medicare under the guise of price "negotiation"—is likely to stymie biopharmaceutical innovation at precisely the time when the world needs more new medicines. Bradway characterized the new law as "a missed opportunity to address the real challenge for patients in [the U.S.], which is the out-of-pocket costs of medicine." He pledged that Amgen would adapt to the more difficult conditions created by the law, and that the company's decades of experience, its global scale, and its manufacturing prowess will enable it "to capitalize on innovation and serve the needs of patients."

Click here to view a replay of Bob Bradway's interview with Bloomberg TV.

Amgen China Marks Ten Years of Serving Patients

Fri, 23 Sep 2022 18:43:56 Z

The year 2012 got off to a bang in China – literally, with some 600 million yuan's worth of fireworks ignited in Beijing alone to mark the start of Chinese New Year. Notable events for the year included publication in August of a new five-year national energy plan establishing ambitious targets for renewable energy generation, the introduction at the National Party Congress in November of the country's next generation of political leaders – and the establishment of Amgen's first direct presence in this vast nation of more than 1.3 billion people.

Since 2012, Amgen China has grown from a handful of colleagues in Beijing and Shanghai to become a large and growing organization with more than 1,000 employees and a presence in more than 100 cities across China. In fact, Amgen's team in China now constitutes more than 40 percent of the company's entire Asia-Pacific workforce.

Nanpo Yin (pictured at center) celebrates the birth of his daughter with his Amgen colleagues in Beijing.

Nanpo Yin is Amgen China's longest-serving employee, having joined the company in 2013 as Supply Chain Director. "I was excited by Amgen's reputation as a biotechnology pioneer and the once-in-a-lifetime opportunity to be part of the team establishing Amgen's presence in China," he said. "It is a great privilege to have been able to participate from nearly the start in our company's efforts to bring our innovative treatments to Chinese patients."

Since its establishment ten years ago, Amgen China has steadily increased the number of innovative medicines it supplies to Chinese patients. The affiliate's first two marketed products — Repatha^® and Prolia^® — have already served more than 1 million patients across China. Amgen's local team is confident they can expand that number much further, since China has one of the world's most rapidly aging populations – and that translates into growing need for medicines to treat health conditions associated with aging.

Through Amgen China's strategic collaboration in 2019 with BeiGene, more patients in China are gaining access to the company's cancer treatments. China accounts for some one-quarter of newly diagnosed cancer cases and nearly one-third of cancer-related deaths each year globally¹, underscoring the urgent need for access to new cancer therapies.

Earlier this summer, Amgen China announced its most recent strategic collaboration – this time with Fosun Pharma for the commercialization across China of Otezla^® and Parsabiv^®.

Reflecting China's growing reputation for high-tech innovation across a range of industries, Amgen China is helping to advance the next wave of innovative treatments for patients in China and around the world by supporting clinical trials of seven candidate medicines targeting cardiovascular disease, inflammation, and cancer. It is also generating data to support new indications for already-marketed medicines.

"Grandma Li" is among the many Chinese patients who have benefited from Amgen's treatments.

Among the many Chinese patients who need new medicines is "Grandma Li." After suffering three years of debilitating back pain, this 60-year-old woman finally consulted her physician. Soon the diagnosis came back: severe osteoporosis. "My doctor told me my bones were as soft as tofu," Grandma Li recalled. Following surgery and a period of post-operative treatment, her bone density increased. "I still want to travel and have fun if I can reinvigorate my bone health!" Grandma Li said.

Bringing innovative medicines to patients is just one way in which the Amgen team is advancing health and well-being in China. Here are a few other examples of how Amgen China is supporting disease awareness, access to medicine, and social development:

To help achieve the government's "Healthy China 2030" vision, Amgen has worked with China's National Health Commission to launch a ground-breaking program on "Building High-Quality and Efficient Health Service System and Empirical Study in the Context of Aging." This three-year program aims to develop a high-quality and efficient service system to help China's population achieve "healthy aging," for instance by quantifying the costs involved in developing a disease management pathway for chronic conditions affecting the elderly. Exemplifying its "predict and prevent" approach to chronic diseases, the program selected the city of Xiamen to pilot a full-cycle management system for high-risk cardiovascular patients.
To improve patients' access to medicine, Amgen has supported the China Charity Foundation in giving certain patients access at no cost to Repatha^®
To improve awareness and prevention of circulatory disease, Amgen partnered with the China Cardiovascular Association (CCA) in 2019 to develop a pan-vascular disease prevention and control plan, and inaugurated the Chinese ASCVD Prevention and Control Centre, charged with helping to prevent cardiovascular events in high-risk patients. The program has since been expanded to include follow-up protocols for Acute Coronary Syndromes (ACS), with a focus on strengthening patient compliance following percutaneous coronary intervention. These initiatives seek to provide optimal care in both in-patient and out-patient settings for highest-risk ACS patients in order to reduce their chances of further cardiac events.
To draw attention to women's bone health, Amgen worked with the China Women's Development Foundation in 2020 to launch the "Joyful Bone" awareness and disease education campaign. In fewer than three years, this program has reached more than 1 million Chinese women and their family members. Also in 2020, Amgen China inaugurated "Fight the Fracture," an educational campaign to help fight fragility fractures, as well as the Power Bone Program, an osteoporosis prevention and treatment initiative that has reached some 8,000 patients at 74 medical facilities across China.
To inspire the next generation of scientists, the Amgen Foundation partnered with Tsinghua University in 2019 to establish the Amgen Scholars Program in China, providing an initial 15 undergraduate students with summer research opportunities at leading educational and research institutions. This August, the Amgen Foundation joined again with Tsinghua University to launch the Amgen Biotech Experience, with 47 students and six teachers participating in the "Foundations of Biotech Labs" course.

Amgen China's efforts to build a welcoming environment for staff and support local communities have earned ample recognition for the affiliate including, most recently, certification in 2022 as a Great Place to Work^®.

"The need for innovative medicines in China is huge," noted Amgen CEO Bob Bradway. "Our medicines – both on the market and in development – line up very well with the health needs of China's aging population. I congratulate all of my Amgen China colleagues as they seek to make a difference for patients and celebrate the affiliate's tenth anniversary."

"As the world's largest pharmaceutical market, China is key to Amgen's future growth," said Murdo Gordon, the company's Global Commercial head. "As its population continues to age, China will need more medicines to manage chronic conditions associated with aging and with urban lifestyles, including cancer, respiratory and inflammatory disease, osteoporosis, and heart disease." Murdo added that JAPAC is expected to contribute some 15% of Amgen's global revenues by 2030, with China being a key contributor to that growth.

Irene Hsu, Vice President and General Manager of Amgen China

Irene Hsu, Vice President and General Manager of Amgen China, is confident that Amgen's future in China is bright. "Our portfolio of medicines is well-suited to address the huge unmet demand for innovative treatments and quality healthcare services," said Hsu. "I'm proud of how our team is embracing our purpose and partnering with stakeholders in the healthcare ecosystem to serve more patients more quickly."

References:

https://www.cn-healthcare.com/articlewm/20211212/content-1294890.html.

Recognizing Global Diversity Awareness Month

Fri, 30 Sep 2022 18:56:38 Z

October is Global Diversity Month, which pays tribute to the diverse minds and beliefs held by cultures around the world. At Amgen, we embrace the strength of our diversity and recognize the contributions of staff to our shared mission of serving patients. We truly believe that our differences lead to better science, which ultimately benefits patients.

A Hashtag For What Needs to Be Said About Asthma

Fri, 17 Dec 2021 03:22:21 Z

For many of us, breathing comes effortlessly. We may not give it any thought at all. Yet, behind every asthma diagnosis is a story to be told – something to be said. To showcase the unique journey of people living with asthma, we are shedding a light on their experiences through #DearAsthma. We encourage people to address asthma head-on and share their response to “What Needs to be Said to Asthma” on their social media channels.

There are approximately 1 million people in the U.S. living with severe asthma that is uncontrolled or biologic eligible.^1-6 That is a lot of stories, all different and distinct from the next.

Asthma is a serious, chronic disease that causes the airways in the lungs to become swollen or inflamed and over-reactive to triggers like pollen, dust or smoke. Severe asthma is debilitating, with patients experiencing frequent exacerbations and significant limitations on lung function and health-related quality of life.^3,4

For the millions of people globally living with severe asthma, breathing is very much at the forefront, and each breath brings unique struggles. Each person’s experience with severe asthma is different. Some say it feels like “waking up to an elephant sitting on your chest” or “breathing through a cocktail straw.” There is no one-size-fits-all profile of the disease.

Visit BreaktheCycle.com for more resources and information about asthma control.

References:

Centers for Disease Control and Prevention. Most Recent National Asthma Data. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed November 2021.
Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.
Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005;172;149–60.
Chung KF, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.
Chastek et al. J Manag Care Spec Pharm 2016;22:848-861.
Chen et al. Curr Med Res Opin 2018;34(12):2075-2088.

Behind the Discovery of a New Homegrown Molecule for Severe Asthma

Fri, 17 Dec 2021 17:59:06 Z

Tezspire^™ (tezepelumab-ekko), a first-in-class medicine for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, was approved by the U.S. Food and Drug Administration (FDA) today (December 17, 2021).¹ The journey to bring this medicine to patients has been a deeply personal one for the team at Amgen. Formerly known as AMG 157, Amgen is excited to introduce Tezspire^™.

Globally, there are approximately 2.5 million people living with severe asthma who are uncontrolled or biologic eligible, with approximately 1 million in the U.S.^2-7 Severe asthma is debilitating, with individuals experiencing frequent symptoms and exacerbations, significant limitations on lung function and a reduced quality of life.^4,5 The complexity and heterogeneity of asthma has made it a historically challenging disease to treat.

By targeting and blocking a key epithelial cytokine called thymic stromal lymphopoietin (TSLP) that sits at the top of the inflammatory cascade and acts as an alarmin for the immune system, Tezspire^™ is able to reduce the release of downstream mediators of inflammation.^1,8 The most common adverse reactions of Tezspire^™ are pharyngitis, arthralgia and back pain.¹

"I'm immensely proud of what we've done here. It's an incredible accomplishment every time a new drug based on science makes it into the hands of patients. That doesn't come easily. It takes more than a village—it takes an army, that army has worked for many years to come to this moment. That's what I'm really proud of," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "To me, this just goes to the heart of what Amgen does, it's why we're here, it's why I come to work every day."

Watch the Tezspire video above to hear about the medicine's journey from the scientists and researchers who brought this treatment from discovery to development as well as from a woman named Erin, who lives with severe asthma.

INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see the Tezspire full Prescribing Information.

You may report side effects related to AstraZeneca products by clicking here.

References:

Tezspire (tezepelumab) US prescribing information; 2021.
Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed November 2021.
Kupczyk M, Wenzel S. J Intern Med 2012;272:121–32.
Wenzel S. Am J Respir Crit Care Med. 2005;172;149–60.
Chung KF, et al. Eur Respir J. 2014; 43: 343–73.
Chastek, et al. J Manag Care Spec Pharm 2016;22:848-861.
Chen, et al. Curr Med Res Opin 2018;34(12):2075-2088.
Corren J, et al. N Engl J Med. 2017; 377: 936-946.

Severe Asthma and TSLP: Fast Facts

Fri, 17 Dec 2021 17:59:06 Z

Here are some fast facts about severe asthma and the role of thymic stromal lymphopoietin (TSLP):

1 million people in the U.S. and 2.5 million people globally live with severe asthma that is uncontrolled or biologic eligible.^1-6
The number of Americans with asthma is anticipated to grow 10% by 2039, thought to be due to increased urbanization, lifestyle changes and rates of obesity.⁷
About 60% of Americans with severe asthma are not getting specialized care.⁸
2x as many asthma-related hospitalizations are experienced by people with severe asthma.⁵
Thymic stromal lymphopoietin (TSLP) is a key epithelial cytokine that sits at the top of the inflammatory cascade and acts as an alarmin for the immune system.⁹
Amgen discovered blocking TSLP may help reduce the number of asthma attacks experienced by patients after it was first discovered that TSLP had a connection to inflammation in the 1990s.
Amgen and AstraZeneca jointly developed Tezspire^™, the first and only biologic approved for severe asthma without phenotypic or biomarker limitations.^9-18

INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

Please see the Tezspire full Prescribing Information.

You may report side effects related to AstraZeneca products by clicking here.

References:

Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed November 2021.
Kupczyk M, Wenzel S. J Intern Med 2012;272:121–32.
Wenzel S. Am J Respir Crit Care Med. 2005;172;149–60.
Chung KF, et al. Eur Respir J. 2014; 43: 343–73.
Chastek, et al. J Manag Care Spec Pharm 2016;22:848-861.
Chen, et al. Curr Med Res Opin 2018;34(12):2075-2088.
American Thoracic Society. Available at: https://www.thoracic.org/about/newsroom/press-releases/journal/2019/uncontrolled-asthma-over-next-20-years-likely-toadd-300-billion-to-us-health-care-bill.php. Accessed November 2021.
Most, J. F. The Journal of Allergy and Clinical Immunology: In Practice, 9(10). https://doi.org/10.1016/j.jaip.2021.05.003
Corren J, et al. N Engl J Med. 2017; 377: 936-946.
Menzies-Gow A, et al. N Engl J Med. 2021;384:1800-1809. DOI: 10.1056/NEJMoa2034975.
Hanania NA, et al. Ann Intern Med. 2011;154 (9): 573-82.
Yancey SW, et al. Respir Med. 2019; 151: 139-141.
FitzGerald JM, et al. Lancet Respir Med. 2018; 6 (1): 51-64.
Castro M, et al. N Engl J Med. 2018; 378 (26): 2486-2496.
Ortega HG, et al; on behalf of the MENSA Investigators. N Engl J Med. 2014;371(13):1198-207.
Bleecker ER, et al, on behalf of the SIROCCO study investigators. Lancet 2016: 388 (10056): 2115-2127.
FitzGerald JM, et al, on behalf of the CALIMA study investigators. Lancet. 2016: 388(10056): 2128-2141.
Wenzel S, et al. Lancet. 2016 Jul 2;388(10039):31-44

A Look Back at the Inspiring “People of Amgen” Series on Instagram

Tue, 14 Dec 2021 01:50:54 Z

Over the past year, a number of colleagues shared their personal stories in the 2021 People of Amgen series on Amgen’s Instagram page, highlighting the human side of Amgen and reflecting the company’s commitment to diversity, inclusion and belonging.

Those who participated shared personal anecdotes about everything from living with an autism diagnosis and managing irritable bowel disease (IBD) to their personal and professional journeys. These stories show how the people of Amgen take responsibility for creating a welcoming, inclusive, and productive work environment where everyone feels valued, regardless of their differences.

We have been inspired by every story and we hope you were too. Click the names below to see them one more time.

View this post on Instagram

A post shared by Amgen (@amgenbiotech)

Bradway Hails Amgen’s Progress Against 'Undruggable' Disease Targets at Two Healthcare Forums

Mon, 13 Dec 2021 17:30:25 Z

Amgen CEO Bob Bradway highlighted the company's biopharmaceutical innovation – and especially its work leveraging human genetic and other data to advance new treatments for disease targets long considered "undruggable" – at two high-profile healthcare conferences: the Galien Golden Jubilee Forum, held in New York on October 28, and the Reuters Total Health Summit, which took place virtually on November 15-18.

This year's Galien Forum marked the 50th anniversary of the Prix Galien, which was created in 1970 to advance biopharmaceutical innovations that serve humanity. Bradway participated in a CEO-level panel discussion exploring "Where Will New Drug Therapies and Vaccines Come From?" Moderated by Pfizer R&D head Mikael Dolsten, the panel included Arvinas CEO John Houston, Biotechnology Innovation Organization CEO Michelle McMurry-Heath, IQVIA Chief Medical and Scientific Officer Jeffrey Spaeder, and Biogen CEO Michel Vounatsos. At Reuters Total Health, Bradway participated in a keynote conversation with Reuters healthcare correspondent Deena Beasley on "Biopharmaceutical Innovation and the Promise of the 'Biocentury'."

"One of the reasons we are investing as heavily as we are in human genetics and in the associated 'omics' around the human genome," Bradway remarked at the Galien Forum, "is to understand at the molecular level which diseases we might be able to address utilizing the new platforms and be able to say to patients across different disease areas, 'we think we have an innovation that may work for your specific disease.' I think we are on cusp of being able to do that quite widely." He added that Amgen sees opportunities in oncology, cardiovascular disease, and inflammation "to use our genetic insights to help us decide where to do clinical experiments that we think the genetics tells us are likely to be successful."

Bradway expressed confidence that Amgen's growing expertise in "proximity biology" – the development of therapies that can engage two or more protein targets simultaneously to induce a desired biological effect – "will enable us to take a lot of targets that were considered undruggable and render them druggable." Asked to identify what achievement he would most like to celebrate in five years' time, he responded that "I hope in 2026 somebody asks what we meant in 2021 when we said 'undruggable,' because I'm hopeful that some of these new technology platforms render that question irrelevant."

Bradway expanded on this point at the Reuters Total Health Summit, commenting that human genetic and other omic data "give us an advantage over relying just on preclinical models." He attributed the biopharmaceutical industry's relatively low R&D success rates to the fact that "historically we haven't had very good proxies for how drugs will behave in humans before we actually take those drugs." Human genetics, proteomics, and transcriptomics give Amgen the means "to identify in advance which therapies or which biologic pathways have a higher likelihood of succeeding based on the fact that we can find particular perturbations of those pathways through human genetics and then leverage that information to hopefully have a better success rate in developing new therapies."

Citing the rapid development of new vaccines and therapeutics for COVID-19, Bradway told his Reuters audience that "the power of our innovative ecosystem has been on full display for the world to see." He warned, however, that government price controls on innovative medicines could "destroy the very system which is bringing forward the innovation that we need." A better approach would be to enact policies to improve patient access, such as measures to cap the out-of-pocket costs paid by patients for innovative medicines.

"It's not a case of having too much innovation," Bradway concluded. "We don't have enough innovation. That's why people are suffering from chronic diseases at such extraordinary rates in our society. These are diseases that we can prevent or delay by adopting innovative medicines. So our focus is on trying to advance innovative medicines and policies that will help favor their adoption."

Amgen R&D Head David Reese amplified Bradway's comments in his own remarks during a live question-and-answer session at the Reuters Summit. Asked how COVID-19 will shape drug development, Reese observed that Amgen and other innovators are now "bringing the trial to the patient rather than the patient to the trial," and predicted that "virtualization of clinical trials will be an enduring change that we're seeing coming out of the pandemic." He added that Amgen is generating massive amounts of human genetic data for use in predicting protein structures, reducing development timelines, and increasing success rates. "The challenge," he concluded, "is integrating [that data], aggregating it, and most importantly analyzing it… It's an absolute revolution and it's playing out in real time right now."

To learn more about the principle of induced proximity click here to view a short animated video narrated by Ray Deshaies, Amgen senior vice president of Global Research. You can also listen to Amgen's podcast series Undruggable to learn how the new wave of discovery, led by new types of multispecific medicines, has the potential to radically alter our concept of how drugs can work and pave the way for new solutions.

Candid Conversations: Ability Bettered Through Leadership and Education (ABLE)

Tue, 13 Sep 2022 20:42:05 Z

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In Amgen’s final Candid Conversations video this year, Peter Griffith, chief financial officer and executive sponsor of Ability Bettered Through Leadership and Education (ABLE) and Noemi Romero, vice president of Operations, Digital Strategy & Capabilities and global chair of ABLE, discuss the importance of an inclusive workplace for employees of differing abilities.

The conversation also reminds us of the increased challenges of those with disabilities working remotely.

11.18.2021 | Candid Conversations: Amgen Veterans Employees Network (AVEN)

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In recognition of Veterans Day/Month, this video features a Candid Conversation between Annalisa Pizzarello, senior vice president, Results Delivery Office, executive sponsor of Amgen Veterans Employees Network (AVEN) and Ben Chu, director Global Program Management - Oncology, global chair of AVEN.

Watch Pizzarello and Chu, who is a veteran, discuss the valuable contributions, teamwork and resiliency of veterans in the workplace.

09.28.2021 | Candid Conversations: Amgen Latin Employee Network

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. This video features a transparent dialogue between Esteban Santos, executive vice president, Operations, executive sponsor of Amgen Latin Employee Network (ALEN) and Kristyna Rodriguez Powell, director of Global Accounting, global chair of ALEN.

Watch Santos talk about the benefits of diverse teams serving patients and the importance of “paying it forward”, and Rodriguez Powell discuss navigating change and how ALEN members encourage and value different perspectives from other ERGs and staff.

08.23.2021 | Candid Conversations: Amgen Early Career Professionals

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. This video features a transparent dialogue between Dave Piacquad, senior vice president, Business Development, Executive Sponsor of Amgen Early Career Professionals (AECP) and Migdaliz Lopez, senior associate, Talent Acquisition, Global Chair of AECP.

Watch Piacquad talk about his passion for developing early career talent, and Lopez discuss how AECP continued to embrace career development amid the pandemic.

06.03.2021 | Candid Conversations: Amgen Pride – LGBTQ+ and Allies Network

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In celebration of Pride Month, this video features a transparent dialogue between Jon Graham, executive vice president, general counsel & secretary, executive sponsor of Amgen PRIDE and Andy Edgar-Beltran, principal quality engineer, global chair of Amgen PRIDE.

Watch Graham talk about his "aha moment," recognizing that people that look like him may not understand the idea of privilege, and Edgar-Beltran discuss the evolution of not just diversity in the workplace but the necessary elements of inclusion and belonging.

05.11.2021 | Candid Conversations: Amgen Asian Association (AAA)

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In celebration of Asian American and Pacific Islander heritage month, this video features a transparent dialogue between Judy Brown, senior vice president, Corporate Affairs, executive sponsor of Amgen Asian Association (AAA) and Cen Xu, executive medical director, R&D, global chair of AAA. Watch Xu open up about her personal experiences of unconscious bias, the wave of anti-Asian hate incidents and how Amgen colleagues are showing support to their Asian colleagues.

The Amgen Foundation recently awarded a $250,000 grant to support Stop AAPI Hate, a reporting and resource center which is fiscally sponsored by the nonprofit organization Chinese for Affirmative Action. This center tracks and responds to incidents of hate, violence, harassment, discrimination, shunning and child bullying against Asian Americans and Pacific Islanders in the United States.

03.02.2021 | Candid Conversations: Women Empowered to be Exceptional (WE2)

Candid Conversations is a video series featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In celebration of Women’s History Month, this video features a transparent dialogue between Murdo Gordon, executive vice president, Global Commercial Operations, executive sponsor of Women Empowered to be Exceptional (WE2) and Nada Obeid, executive director, U.S. Value & Access, global chair of WE2.

Watch Obeid share her experience taking care of her family while navigating remote work and Gordon discuss the impact COVID-19 is having on women in the workplace.

02.10.2021 | Candid Conversations: Amgen Black Employee Network (ABEN)

Amgen kicks off a short video series, Candid Conversations, featuring Amgen leaders addressing topics of Diversity, Inclusion and Belonging — issues at the intersection of the workplace and society. In celebration of Black History Month, the first video features transparent dialogue between David Reese, executive vice president, R&D and executive sponsor of the Amgen Black Employee Network (ABEN), and Mike Edmondson, a vice president in our Global Commercial Organization and immediate past global chair of ABEN.

Watch Reese share his “aha moment” and Edmondson chat about his personal experiences with unconscious bias. Both Reese and Edmondson also discuss last year’s death of George Floyd and how its aftermath shaped their views on issues of society, inequity and racial justice.

Advancing All Angles of Care for Cancer Patients

Mon, 13 Dec 2021 17:30:24 Z

At this year's annual American Society of Hematology (ASH) conference December 11-14, healthcare professionals, researchers and industry leaders will come together to share the latest advances in care for blood cancer patients. While medical congresses like ASH showcase the great strides that have been made in the treatment of cancer, they are also important reminders of the unmet needs that remain for patients.

Amgen is striving to meet these needs through a 360-degree approach that spans All Angles of Care for people living with cancer. Advances in medicines are an incredibly important aspect, but they are only one piece of the comprehensive care puzzle needed to attack cancer from all fronts. People with cancer need better and faster access to life-changing treatments and the right care solutions across their spectrum of needs—from prevention, to supportive care that helps to ease symptoms and the effects of cancer and its treatment.

"At Amgen Oncology, we are driven by the belief that we can do more for people with cancer by delivering a spectrum of cancer treatment options," said Mhairi Strachan, vice president, Global Oncology Marketing at Amgen. "From launching transformative medicines across core areas like hematology, lung, prostate and gastrointestinal cancers to serving patients comprehensively with outcome enabling solutions like supportive care and biosimilars, we know that we can raise expectations for what science, medicine and global health ecosystems can do."

Watch the new video above to learn more about how Amgen Oncology is advancing all angles of care to transform what's possible for people living with cancer.

Innovation² with Jane Parnes and Nina Tandon

Mon, 13 Dec 2021 17:30:25 Z

From helping pioneer the field of genetic engineering to creating potential new methods to regrow bone, no challenge is too great for these innovators featured in the latest episode of Innovation². Jane Parnes, executive medical director of Medical Sciences at Amgen, and Nina Tandon, CEO and Co-Founder at EpiBone, Inc., recently spoke virtually about their most impactful teachers, a shared love of running marathons and their contributions to the field of engineering.

In this episode, Jane and Nina discussed how science and academia have been constant undercurrents throughout their lives. Jane shared details about her time at Stanford and her decision to leave a tenured position to work at Amgen and study new options for severe asthma. Nina also reflected on her time in academia and how she too was at cross-roads, facing the decision to pursue a career in teaching or clinical development. Both agreed focusing on helping to make a difference in the lives of patients was the defining factor of their decisions.

Innovation² is a video series created by Amgen in collaboration with The Nation of Artists to highlight how some of the brightest minds think about innovation. The series sheds light on what fuels tenacity for today's innovators and how pushing against the status quo allows them to truly make a difference in the world. Each episode features one innovator from within Amgen and one innovator from another sector. The conversations are often inspiring and entertaining, highlighting personal contributions and today's cutting-edge science and innovation.

You can view Jane and Nina's episode along with the rest of the series on Amgen's YouTube channel.

From Prison to PhD: The Journey of Education and Redemption

Wed, 15 Dec 2021 23:27:46 Z

He can be driving in his car, approaching a traffic light, when it goes from green to yellow. Suddenly, there is a tightness that grips him. The paranoia arrives in waves. Is there a police officer nearby? I can't take the risk and accelerate. Might get targeted for speeding. Can't run the light – what if it turns red while I'm going through the intersection?

In those moments, he is filled with anxiety. He has worked too hard and too long to become Professor Stanley Andrisse, a doctor of endocrinology teaching students at Howard University about cells, biology and the causes of hormonal diseases like diabetes. He has rooted himself far too deep into being a loving husband and father to a young daughter.

He has moved too far from being Inmate No. 1132834.

"It's a state of feeling that I could be sent back to prison for any one thing," Andrisse said.

Stanley Andrisse is the founder and executive director of the nonprofit From Prison Cells to PhD. Photo courtesy of Stanley Andrisse.

It's been more than a decade since Andrisse was serving time in a state prison for selling drugs. So much has changed in that time and yet, the past can come rushing back at a moment's notice. He still eats too fast sometimes – a habit picked up from prison. Sleep is sometimes disrupted by dreams.

"I witnessed stuff no one should ever have to witness," he said. "I got out and I thought I was unscathed mentally and psychologically. I could not have been more wrong."

Despite the post-traumatic stress disorder (PTSD) he was diagnosed with, he still found his way to becoming a doctor and scientist. He is also a husband and father. Andrisse is now hoping to help others move beyond the stigma of once being incarcerated and having that be a barrier to re-entering society and rebuilding their identity with his nonprofit, From Prison Cells to PhD.

This year, with the help of a $100,000 grant from the Amgen Foundation, the nonprofit hopes to raise awareness about the power of education and its restorative role for the incarcerated. It was one of dozens of grants issued by the Amgen Foundation over the past year aimed at advancing racial and social justice across the United States, including in science education.

A portion of the grant money for Prisons Cells to PhD from the foundation went to create videos highlighting some of the success stories from the Prison Cells to PhD programs. It also ties to the Amgen Foundation's work with LabXchange to make STEM education accessible and to encourage and prepare everyone who has a desire to pursue a career in science.

"Highlighting Dr. Andrisse's powerful story can change people's mindset towards those who have served their time — from unending punishment to unlocking potential," said Scott Heimlich, vice president of the Amgen Foundation. "Through a commitment of more than $10 million to address racial and social inequities, the Amgen Foundation is proud to support organizations like this one across our communities."

Prison in America

According to the nonprofit Prison Policy Initiative, there are more than 2.3 million people being held in 6,000 correctional facilities run by thousands of agencies. The incarceration rate for the United States is 664 per 100,000 people, and 24 states alone have a higher rate of locking people up than the next country on the list – El Salvador, which locks people up at a rate of 562 per 100,000.¹

But the rate of incarceration doesn't reflect racial disparities in who is imprisoned, according to the Pew Research Center.

Pew noted this year that the rate of Blacks being imprisoned has fallen by a third since 2006, but there remains a wide gap between Blacks and whites when it comes to prison populations.²

The data, culled from the Bureau of Justice Statistics, showed the rate of incarceration for Black adults was more than five times that of white adults – 1,510 per 100,000 compared to 268 per 100,000. Black adults were also incarcerated at a rate twice that of Hispanics.³

Black Americans make up 12% of the U.S. adult population but represent 33% of the sentenced prison population, according to the Pew report released last year.

It's not much better for Black women, either.

The rate of imprisonment for Black women in 2019 was 83 per 100,000, according to the nonprofit group The Sentencing Project. That rate is almost twice that of white women, who were incarcerated at a rate of 48 per 100,000.⁴

Systemic racism in the justice system has been documented for years but has taken on a heightened awareness in the wake of the George Floyd murder and the Black Lives Matter movement that has sought to expose racial disparities when it comes to contacts with law enforcement and the court system.

Those disparities start young. Research shows a thread of racial bias that runs from school-aged Blacks who are often more frequently targeted for childhood suspensions, expulsions and subsequent arrests than whites are for similar offenses. Studies also show Blacks are more likely be denied bail and diversion, face harsher charging decisions and poor legal representation that lead to increased risks of wrongful convictions and longer sentences.⁵

Andrisse said about a quarter of formerly incarcerated people don't have a high school diploma or a GED. He said this was where he saw his chance to make an impact.

"We are literally trying to change the game," he said.

The Game

Andrisse was the youngest of five children growing up in the Ferguson-Florissant area of Missouri. The son of Haitian immigrants, he wrote in his new book "From Prison Cells to PhD" that identity was a struggle from an early age.

"Life as an immigrant family was different. We are different. We even looked different than most Black kids – slightly in our physical features being mixed with Taino natives of the Caribbean and Africans," he wrote. "But mostly in our dress as my Haitian parents didn't know, understand or live by hip-hop, R&B, Black culture."

He said that he learned early on how poverty drove a desire to escape it by any means necessary. Dealing drugs appeared as the more accessible path for black youth in his area and, as a high schooler, he saw the dealers driving fancy cars and flashing wads of cash and he figured it was a way to get ahead. It was "the game."

Despite getting sucked into that world, Andrisse also kept a foot in school and got a diploma and secured a scholarship to play football at Lindenwood University. But he kept dealing drugs throughout college, making hundreds of thousands of dollars trafficking narcotics across state lines.

It all ended for him in 2006, when Andrisse was swept up in a U.S. Drug Enforcement Agency bust that ultimately landed him in prison – staring down a 10-year sentence.

He said nothing prepares a person for prison life. He said he didn't sleep for the first few weeks for fear of being assaulted. Prison time is hard time and requires living in survival mode.

"Constant fight or flight," he said.

Because he had gotten his bachelor's degree and had an education, he began to see that continuing that process was going to be his salvation. He always liked science and biology. Reading, learning and having a goal is what kept him going in prison.

Then he learned his father's diabetes was worsening. He made a commitment to begin studying that disease state and thought he'd like to get a doctorate in endocrinology. He began applying to colleges and that's when he learned how the odds were stacked against him – and others locked up in prison.

Removing Stigmas

The question on job and college applications asking applicants if they have been convicted of a crime fills those who have been convicted with dread—and knowing that this is on applications often causes many to simply not even apply.

Syrita Steib, executive director of the New Orleans-based nonprofit Operation Restoration, said it steals hope and can resign those seeking to get a job or go back to school to believe it's over before they even start.

"You know the places that don't discriminate for hiring based on that?" Steib asked. "Construction, fast food – the job selections are few."

Syrita Steib is the executive director of the nonprofit Operation Restoration. Photo courtesy of Syrita Steib.

Andrisse has been pushing with his nonprofit to change the laws and remove the stigma of that box on both job and college applications. Steib has fought to change this as well and Operation Restoration was a sub-grant recipient of the foundation grant to Andrisse's nonprofit.

Currently, about a dozen states and several local municipalities have "banned the box" and don't require applicants to answer the conviction question initially. Fewer than a half-dozen states have barred colleges and universities from asking it. California, where Amgen is headquartered, saw a ban the box law take effect in 2018. It prohibits requiring potential hires to disclose criminal histories until they are deeper into the application and hiring process.

When Andrisse was in prison, he was denied entry into every university he applied to – except for St. Louis University. He got in with the help of a mentor and subsequently got his master's degree. He then got his doctorate from there. Graduating near the top of his class, he was offered a research position at Johns Hopkins University. Then came the professor position at Howard University. And the nonprofit he started. Now he's also on a mission to help others.

Never too Late

He has testified on behalf of a federal law that bans the box and has met with lawmakers at state and federal levels attempting to get it changed. He said he is trying to get people to reconsider what redemption looks like.

Andrisse said his nonprofit has helped people across the country, providing education scholarships, mentorships and the recidivism rate among the more than 150 participants that completed the peer to peer (P2P) program is at 1%.

One of the best redemption stories he recalled hearing was of a man imprisoned in Colorado in a prison where he was rarely allowed outside the cell. Andrisse said he was only 17 when he went away for carrying a weapon and for several burglaries.

Majid Mohammad was tried as an adult.

But Andrisse's nonprofit reached Mohammad and he has never forgotten him. Mohammad told of how one night, he could see a sliver of sky and the stars on a clear night and began to dream about what it might take to get into space. Mohammad is now in an astrophysics PhD program and one of the subjects in the video.

"Questions about the design of the universe and how and why it operates the way it does really sparked an interest in my turning to academia," Mohammad said in the video. "However, I didn't think it was possible to earn a PhD in astrophysics – or even earn a PhD in anything."

But Mohammad said he was inspired by other mentors in the P2P program and he now hopes to pay it forward by inspiring others to pursue higher education.

Andrisse said inspiration is a big part of the mission. He wants to provide hope to anyone who is looking for a way forward because any life at any time has the possibility for redemption. Andrisse himself said he is inspired by the words his own father told him before he died several years ago.

They are words that he feels can apply to his life and they are words that he sees in other's lives, too.

It's never too late to do good.

References

"State of Incarceration: The Global Context" Emily Widra and Tiana Herring for Prison Policy Initiative. September 2021
"Black Imprisonment Rate in the U.S. Has Fallen by a Third Since 2006" John Gramlich for Pew Research Center. May 2020
"Prisoners in 2018" E. Ann Carson for U.S. Department of Justice, April 2020
"Incarcerated Women and Girls" The Sentencing Project November 2020.
“A History of Tolerance for Violence Has Laid the Groundwork for Injustice Today” Jennifer Rae Taylor for the American Bar Assocation, May 2019

Accelerating R&D to Speed Medicines to Patients

Wed, 03 Aug 2022 17:57:57 Z

Show Transcript

If scientists can deliver vaccines for COVID-19 in under a year, why does it normally take a decade or more to develop other types of medicines? There's a long way and a short way to answer that question.

The long way is to describe the myriad steps in the R&D process and the years of testing needed to show a drug's benefits outweigh its risks. The short answer is drug development takes too long and needs to move faster. Much faster.

Even before the pandemic showed what science could do when spurred by a global crisis, speed had emerged as a top strategic priority for Amgen's R&D group. "Historically, it takes 12 to 14 years on average for a drug to go from an idea in the laboratory to an approved medicine that's available to patients," said David Reese, executive vice president, R&D. "Amgen has already reduced its drug development timelines by about three years, and there is still ample room for improvement."

"We're focused on diseases where patients' lives are literally at stake," said Rob Lenz, senior vice president, Global Development. "When you're facing an illness like cancer or heart disease, you don't want therapies 20 years from now—you want them now."

David Reese, executive vice president, Research and Development

That urgency felt by patients can prompt drug development teams and regulators to work together to expedite breakthrough therapies. A case in point is a recently launched Amgen medicine for lung cancer that received FDA approval just 33 months after its entry into the clinic. While examples like this show it's possible to dramatically accelerate promising programs, Amgen's broader goal is to make speed the norm and not the exception across its clinical pipeline.

"We are applying speed levers in multiple areas, from digital technology and innovative study designs to regulatory partnerships," said Kimberly Clemenson, vice president, R&D Transformation. "Our goal is to help each drug development team integrate as many of these levers as possible to accelerate progress."

Balancing priorities

Speed in R&D is intertwined with other priorities that place limits on how fast a drug can advance. There are strict limits that pertain to patient safety and regulatory compliance. No potential therapy can move forward without meeting these bedrock commitments.

Speed is also constrained by the need to manage the high cost of drug development and improve success rates. The estimated cost to deliver a new medicine has risen to $2.6 billion, a sum that reflects the expense of the roughly 90% of clinical programs that fail to yield an approved therapy.

"To increase success rates, teams can accrue more data at each stage of development, but that makes the program go slower," said Lenz. "Optimizing for cost by staging your investments also slows you down, while optimizing for speed tends to drive up the cost."

One way to manage these tradeoffs is to prioritize speed over cost by investing aggressively. This approach makes sense if there's strong evidence that a test drug is likely to succeed in the clinic and help patients with serious illness who have few if any good treatment options.

At Amgen, programs with exceptional promise can earn a "Fastlane" designation. "With the Fastlane approach, you identify the theoretical minimum time needed to advance a drug, and you do everything you can to achieve that level of speed," said Tara Arvedson, executive director, Research.

For example, in a typical drug development program, you delay high-cost activities—like creating large batches of test drug for clinical trials—until you're sure the drug will actually make it into the clinic. In a Fastlane program, you plan for success and do more work in parallel versus sequentially. More staff are assigned to Fastlane programs, and they get first dibs on support from scientists who assess a molecule's safety and other key attributes. Preparation for clinical trials also starts earlier to eliminate "white space," or the planning time that is usually sandwiched between one stage of development and the next. Together, these approaches can trim up to five years or more off the development time for a successful medicine.

But not every program can get top-priority treatment. "The Fastlane approach is reserved for programs where we have the greatest conviction or see the greatest need," said Clemenson. "That's why we're exploring other speed levers that could be applied more broadly across our entire portfolio of products."

Innovation in the clinic

Since most of the time required to develop a drug is consumed by clinical trials, many speed levers are aimed at getting answers more quickly in the clinic. They include adaptive clinical trials and other novel study designs, applying genomics and proteomics to identify patients who are more likely to need a test drug and show clear benefits, and greater use of real-world evidence and data to replace some or all of the data that is normally collected through a clinical trial.

"With adaptive designs, you can monitor the incoming data and modify the protocol based on what you're learning as the study unfolds," Lenz noted. If pre-established criteria are met, a range of adaptations can be made, including dropping or adding doses, increasing the size or duration of the trial, and observing which types of patients the drug really helps and enrolling more of them.

In general, this flexibility makes it possible to design smaller studies that deliver clear results in less time. "The sooner we can be confident that a drug or a dose of a drug either works or doesn't work, the sooner we can either advance that drug or stop evaluating it in patients," said Lenz.

Genetic and proteomic data can help solve a problem that inflates the size and duration of many studies. Just as an aspirin can't relieve a headache in someone who doesn't have a headache, a test drug can't prevent a disease from becoming worse in a person with stable disease. Until recently, it was difficult to identify people at high risk for disease progression. This uncertainty is normally addressed by studying more patients for more time to ensure you have enough of the right patients to show the drug's true benefits if it works.

Polygenic risk scores are helping to reduce these uncertainties. Polygenic means many genes, and a polygenic score calculates risk based on the collective effects of numerous common genetic variants in DNA—up to millions of variants in some cases. This approach has shown that people who appear to be at low to moderate risk, based on standard diagnostic tests, may actually be at serious risk for disease progression.

"A drug's treatment effect should emerge sooner and more clearly in patients at greater risk for poor outcomes," said Lenz. "At Amgen, we're using human genetics and related data to reduce the size and duration of our trials, increase the probability of success and the size of the treatment effect, and get our medicines approved and into the hands of the patients who need them much sooner."

Applying digital innovation to execute faster trials

The director Alfred Hitchcock once said that actually making a movie was boring compared to planning the whole film in his mind. A similar perspective has long held sway with regard to running clinical trials. "Traditionally, the actual execution of clinical trials has not been viewed as an innovation-rich activity," said Lenz. "But that is changing."

Rob Lenz, senior vice president, Global Development

"The speed of a trial largely depends on getting patients enrolled as quickly as possible, which in turn depends on building a network of high-performing study sites," said Taras Carpiac, executive director, Process Improvement. "The traditional way to select study sites has been to send surveys to potential investigators and say, 'Here's the rough design of our study. Would you like to participate? And how many patients do you think you can enroll?' With that approach, we can only take a few factors into account, like how many patients an investigator has enrolled in previous trials."

Predictions based on a handful of factors may not be very accurate, said Julie Argento, director, Global Clinical Program Management. "Across the industry, roughly 15% of sites that sign up for a trial do not enroll a single patient, and that can be higher for some disease indications." The resulting lag slows down the entire trial.

To get better predictions, Amgen is turning to digital innovation and artificial intelligence. "By implementing a machine learning approach, we can now consider hundreds of characteristics when selecting study sites," said Argento. "We can identify key drivers of enrollment, including specific patient populations in different geographies, a site's research capabilities and infrastructure, available staff, experience with genomic screening, and so on. This allows us to differentiate sites that are likely to be strong enrollers as well as sites predicted to be non-enrollers."

Lowering burdens to boost diversity

Richer analytical data can also help to pinpoint aspects of a study's design that might shrink the number of patients who qualify or discourage patients or investigators from participating. "Industry-wide, an alarmingly high percentage of investigators never choose to do a second trial," said Carpiac. "It can be too much of a hassle for a medical practice that isn't built around running trials."

The good news for patients is that we're seeing more investment than ever in biotechnology, which is leading to the discovery of more potential new medicines. But that also means unprecedented levels of competition within the industry, with multiple companies pursuing nearly every drug target that looks promising. Scientific innovation is still essential, but speed is becoming more and more important to the success of any new therapy.

— Rob Lenz

The extra work—recruiting and evaluating patients, in-depth diagnostic tests, collecting, inputting, and cleaning data, etc.—can overwhelm an already busy healthcare practice. These burdens can be eased by simplifying the protocol as much as possible to generate the needed data and by collecting much of the data directly from the electronic medical records of study participants. "The idea is to design the study so that it fits more seamlessly into standard medical practice," said Carpiac.

Patient-centric study designs can also speed up recruitment by making it easier to participate. According to industry metrics, patients enrolled in trials travel more than 50 miles roundtrip on average for each clinic visit. "These are often people whose lifestyle is already severely compromised by disease," Carpiac noted. Reducing the number, duration, or difficulty of site visits can lower barriers that dissuade patients from enrolling in trials or cause them to drop out of a study after it starts.

Toward that end, Amgen is making greater use of decentralized approaches wherever feasible. Some of these solutions began as necessities due to the COVID-19 pandemic, but they are now being embraced as ways to speed up enrollment in trials by making them more patient-friendly, said Carpiac. "Decentralization can mean anything from home healthcare visits and telemedicine to collecting data through wearable devices or shipping clinical supplies directly to patients' homes."

Reducing participation burdens on patients as well as sites can also advance the goal of improving clinical trial diversity. Democratized trials can expand the clinical research landscape beyond large academic health centers to encompass more community-based practices, while ensuring that the participants in a study are more characteristic of the broader patient population.

Historically, Amgen has excelled at delivering first-in-class medicines. Of the 20 innovative therapies in Amgen's product portfolio, 13 have earned a first-in-class designation and three more are based on earlier first-in-class mechanisms developed at Amgen. That track record will be more challenging to maintain going forward.

"The good news for patients is that we're seeing more investment than ever in biotechnology, which is leading to the discovery of more potential new medicines," said Lenz. "But that also means unprecedented levels of competition within the industry, with multiple companies pursuing nearly every drug target that looks promising. Scientific innovation is still essential, but speed is becoming more and more important to the success of any new therapy."

"The mRNA vaccines developed in response to the pandemic has shown us what can be done and what the edge of achievability looks like," said Reese. "That's what we should be striving to achieve every day."

A New Way to Connect Psoriatic Disease Patients with Healthcare Providers

Tue, 08 Feb 2022 21:03:43 Z

Like many organizations across the world, the Bath Institute for Rheumatic Disease (BIRD) was forced to adjust its approach to patient engagement due to the COVID-19 pandemic. The United Kingdom-based patient organization quickly pivoted from organizing in-person patient gatherings to expanding its virtual offerings, including a podcast series and targeted social media advertising campaigns, to reach people living with psoriatic arthritis and their caregivers in their homes.

This revamped approach saw great initial success and served as the inspiration for the organization's application to Amgen's UPLIFT Innovation Challenge, an initiative launched in partnership with the International Federation of Psoriasis Associations (IFPA). The goal of the initiative was to encourage patient organizations to develop actionable solutions for challenges faced by the psoriatic disease community and their healthcare providers, as identified by the UPLIFT survey.

With over 22 applications received from patient organizations around the globe, BIRD was selected to receive a one-time grant of $25,000 to bring their solution, "Digital Engagement for PsA Patients and Families," to the psoriatic disease community.

BIRD's proposed solution will use patient feedback to develop clinician-led webinars and create refreshed advertising to drive patients to their podcast series. "By deepening patient knowledge, we aim to change expectations around treatments and outcomes to boost patients' confidence in asking questions to the healthcare professionals who join the webinars," said Celia Mead, director of BIRD.

The webinars will include insights from patients in advance to ensure sessions cover information that is most meaningful to them and that patients are ready and confident to interact. With many people in the psoriatic disease community still not attending doctor appointments in person or waiting longer, accessibility was also key. "We want to make these webinars accessible so that during the sessions, patients, families and caregivers will be able to ask questions to better understand their condition," Mead continued.

Psoriatic arthritis patients continue to face challenges in managing and communicating the full impact of their disease with their healthcare providers – this has only increased with the COVID-19 pandemic. "We have always looked for ways to deepen patients' knowledge of their conditions, but the pandemic has caused some individuals to feel increasingly anxious and isolated," Mead explained.

BIRD's virtual webinars and digital advertising campaign aim to address these challenges directly and provide patients with a way to improve their standard of care, without leaving the comfort of their homes.

"We appreciate that companies like Amgen are launching these types of initiatives because it allows our organization to be creative and innovative in our ideas, rather than prescriptive, to ultimately support patients," Mead said.

Visit BIRD's website at www.birdbath.org.uk to learn how you can get involved.

COVID-19 Accelerates Biopharmaceutical Innovation, Bradway Says at Annual Investor Conference

Mon, 15 Nov 2021 19:37:33 Z

The COVID-19 pandemic has claimed roughly five million lives worldwide, upending the world as we once knew it. Now imagine if another disease came along that would dwarf the pandemic's death toll. How frightening would that be? Well, it's already here. It's heart disease and it's responsible for nearly 18 million deaths a year.

Bringing the same energy to bear on heart disease and other chronic conditions that we've brought to the pandemic was the topic of a panel discussion featuring Amgen CEO Bob Bradway and other healthcare industry leaders at this year's Piper Heartland Summit, held in Minneapolis, Minnesota. Bradway's fellow panelists were Cleveland Clinic CEO Tomislav Mihaljevic, United Health Group CEO Andrew Witty, and Medtronic CEO Geoff Martha.

Bradway characterized the rapid development of COVID vaccines as "an extraordinary scientific triumph," and noted that the previous record for developing a new vaccine – the preventive shot for measles – was four years. He expressed hope that the unprecedented degree of cooperation among healthcare companies, regulators, and policy-makers during the COVID era will persist even after we have turned the corner on the pandemic.

"If we brought the same energy to cardiovascular disease that we brought to the pandemic," Bradway observed, "we would put a huge dent" in a disease that claims some 660,000 lives and imposes more than $360 billion in costs each year in the United States alone. What's more, he said, we can predict those patients who are most vulnerable to heart disease and we have the tools to help reduce their risk of experiencing major life-changing events, such as heart attacks or strokes.

Bradway expressed excitement about the industry's growing ability to develop therapies targeting genetic mutations that have long been considered undruggable. Emerging technologies "make us wonder whether the whole genome is now finally druggable," he said, meaning that we are "potentially headed for a period of productivity that none of us is really talking about now."

Asked if he believes the biopharmaceutical industry has received sufficient credit for its innovation during the pandemic, Bradway responded that COVID has reinforced not only the confidence of people who were already inclined to believe in the power of innovation, but also the skepticism of those who view patent rights as barriers to access. He pointed out that "society benefits from the years of data exclusivity and intellectual property protection that we are granted for doing the work that we do," adding that anti-inflammatory medicines available in generic form "have contributed to the success we've enjoyed so far in wrestling this pandemic to ground."

Asked how COVID has affected Amgen, Bradway commented that it prompted us and companies throughout the industry to improve the speed and efficiency of clinical development. "We figured out new ways to enroll patients, to monitor them remotely, to use providers in the healthcare system differently than we had in the past, and that is definitely here to stay." He noted that while some recent improvements in clinical development would have occurred even in the absence of COVID, "they were clearly accelerated by the pandemic. That's good news for patients, innovators, and the whole healthcare system."

In a First for Industry, Murielle Veniant-Ellison Honored With 2022 Havel Lectureship

Wed, 03 Aug 2022 17:57:55 Z

In the field of lipid research, there is no higher honor than being chosen to give the Havel Lecture at the annual Deuel Conference on Lipids. The list of past lecturers reads like a Who’s Who of prominent researchers, including 17 members of the National Academy of Sciences, four of whom are also Nobel laureates.

Since the lectureship began in 2002, no scientist based in industry has received this prestigious honor—until now. The 2022 Havel Lecture will be given by Murielle Veniant-Ellison, a scientific executive director in Amgen’s Cardiometabolic Research group.

The selection of Veniant-Ellison highlights the respect she enjoys among peers for her long-term success in producing and publishing ground-breaking science. Her next publication will bring her personal tally to 100, which includes a high percentage of papers appearing in top-tier journals. Much of this research reflects work done at Amgen with her group and in collaboration with many different teams and scientific colleagues.

“I have been to the Deuel Conference for 25 years and have spoken there before, but not as the keynote,” said Veniant-Ellison. “I have to admit when I got the phone call telling me I had been chosen, I could not believe what I was hearing. My first thought was, ‘Am I up to the task?’ but I quickly said, ‘Of course I’ll accept, and thank you for thinking about me and giving me the opportunity.’”

The Deuel Conference focuses on the biology of lipid, or fat, metabolism and its impact on numerous interrelated diseases, including diabetes, obesity, NASH, heart failure, and coronary artery disease. The event is organized by the American Society for Biochemistry and Molecular Biology, and the 2022 conference will be held on March 1-4 in Monterey, California. The keynote lecture is named for Dr. Richard J. Havel, a pioneer in the field, and Veniant-Ellison’s topic will be “Targeting dual mechanisms for treating obesity.”

While Veniant-Ellison’s research across her career spans the breadth of cardiometabolic disease, she has a particular passion for obesity. Her interest is driven by a belief that patients with obesity need more than admonitions to eat less and exercise more.

“I never thought that obesity was just a lifestyle problem,” said Veniant-Ellison. “Caloric intake and energy expenditure are going to contribute to obesity, but that isn’t all there is to the disease. We now know that there are many genes that increase the risk for obesity, so if genetics are involved, it’s not just about lifestyle. It’s a real disease, and we've got to do something about it, because obesity is at the root of other problems like diabetes and heart disease, and it even increases the risk of dying from COVID-19.”

Forgoing the beach for summers in the lab

Veniant-Ellison traces her interest in science back to her childhood in France. “I grew up in a very small village, and my dad was the director of the village school,” she recalls. “Our apartment was above the classrooms, and the students were breeding guinea pigs to raise money for the school. Since I was always on site, I took care of the guinea pigs, and I became very attracted to thinking about animal life and their physiology. I didn’t know what a career in research meant at the time, but I knew it would have something to do with animals. I thought I would become a veterinarian, but that eventually turned into an interest in the life sciences and biology.”

In France, students choose their field of interest early, at around age 16. Veniant-Ellison chose to study biology in her lycée (high school), and then at the University of Dijon, where she received both her Bachelor of Science and a Ph.D. in Pharmacology.

“In university, I started doing summer internships at Hoffmann La Roche,” she recalls. “Some people go to the beach for long summer holidays, but I was working in the lab. My friends would come back very tanned, and I was very pale, but I had done a lot of research.

“I decided to stick with research because I loved it so much. For me, the in vivo pharmacology where we get to see the effects of novel compounds in experimental animal models was the driving force for getting me up in the morning. I still love figuring out how biology works.”

Perseverance pays off

After a post-doctoral fellowship learning molecular biology at the Centre for Genome Research in Edinburgh and five years of research at the Gladstone Institute of Cardiovascular Disease in San Francisco, Veniant-Ellison accepted a job at Amgen in 2000.

One of her first assignments was to work with the clinical team for leptin, an Amgen obesity program that started out with high hopes and significant media coverage. But while molecules based on this hormone produced significant weight loss in mice, the results in human trials were disappointing, and the program was terminated.

In the years that followed, Veniant-Ellison’s primary focus was diabetes. As her responsibilities and the size of her research group expanded, her team also worked on investigational heart failure therapies. Throughout those years, she never lost hope in finding safe and effective obesity therapies—even during a lean stretch when the disease was not high on Amgen’s list of priorities.

“For a while, our obesity research program was in survival mode, but I still knew what we had here at Amgen was special,” Veniant-Ellison said. “Our group has always been very talented, and we really believed that we could make a difference. So, my philosophy was to keep the group focused on finding the molecules that would generate the most weight loss.”

The fruits of that perseverance can be seen in Amgen’s early-stage clinical pipeline, which includes an investigational therapy for obesity. AMG 133 is a bispecific antibody-peptide conjugate that targets gastric inhibitory polypeptide receptor (GIPR) and glucagon-like peptide 1 (GLP-1). A Phase 1 study is now underway to determine this molecule’s safety, tolerability, and pharmacological properties in human volunteers with obesity.

After a long road, cautious optimism

The broader field of research into obesity and related diseases has made significant strides in recent years. Medicines that mimic GLP-1 have already been approved to treat diabetes, and they have also been associated with weight reduction. One GLP-1 therapy was recently approved for that indication.

Veniant-Ellison believes that the key to continued progress may lie in engaging multiple targets with impacts on obesity, including GLP-1. “Obesity is a polygenic disease and multifactorial, so tapping on different pathways simultaneously may help to decrease weight to a greater extent than if we hit just one target at a time,” she observed. “In our animal studies, we found a synergistic effect by combining a GLP-1 peptide and anti-GIPR antibody. These bispecific molecules are doing something very unique at the molecular level.”

There’s a lot of work still to be done to assess the therapeutic potential of AMG 133—its benefit-to-risk ratio, and the types of patients most likely to achieve good outcomes. Genetic and protein markers may help to pinpoint those patients.

“It’s been such a long road to get to where we are now, so I don’t want to celebrate too soon,” Veniant-Ellison said. “But I do feel honored by the opportunity to give the Havel Lecture, and I'm excited and cautiously optimistic that an Amgen molecule could wind up helping patients. If we want to benefit society, we need to find new options for people with obesity. Effective treatments could mitigate the risks for a lot of other diseases as well.”

Supporting Access to Nutritious Foods in Amgen’s Community

Mon, 22 Nov 2021 22:32:17 Z

No one should worry about whether their family will have nutritious meals to eat, especially not around Thanksgiving. As a sponsor of Food Share Ventura County, Amgen supports its Southern California community year-round by supporting a food bank that provides nutritious food to around 300 different food pantries in the region. Ian Thompson, Amgen’s senior vice president, U.S. Business Operations, also sits on Food Share’s board of directors.

In the video below, meet Bertha Preciado, who is both a volunteer and recipient at Nyeland Promise, a local food pantry in Oxnard, California, near Amgen’s headquarters in Thousand Oaks. Food Share helps ensure Nyeland Promise can offer the community a wide range of nutritious foods, from canned goods to fresh produce and eggs, so recipients have nutritious, balanced meals for their families.

“I like to help, even more so during these times we are living in, times where all people are in need and we are in need,” Preciado says. “Because now, during this time, my husband lost his job because of the pandemic. It made a great impact here at the house.”

Videos for this program won Platinum and Gold MarCom Awards, which are awards given out to marketing and communications professionals.

Amgen Featured in Video Series Highlighting Leading Innovators

Fri, 05 Nov 2021 18:53:38 Z

“This is an incredibly exciting time to bring the tools of technology to bear on the challenges of biology.”

So says Amgen CEO Bob Bradway in the latest “Innovation Realized” series of videos produced by the Nasdaq-100 stock index and highlighting how “innovators push the boundaries of what's possible to change lives and reshape reality.”

According to Bradway, “Our mission is to advance innovative new therapies for patients who are suffering from serious illnesses… Over the course of the last 40 years, we moved from having one medicine that addressed kidney disease to now having 25 medicines that we are able to bring to patients across 100 countries around the world.”

Still, the best may yet be to come.

“One of the most exciting things right now at Amgen is tackling what we call the ‘undruggable,’” says Dave Reese, Amgen’s head of R&D. “Eighty or 85% percent of protein targets that drive disease currently can't be broached with this generation of technologies. We are rapidly learning how to engineer new molecules that will make the undruggable, druggable.”

Once these molecules are created in the lab, proven in clinical trials to be safe and effective, and approved by regulators, they then need to be manufactured at scale—a complex process that often uses living cells.

“We have been one of the companies that has continuously pushed the envelope on translating great discoveries into novel medicines,” says Arleen Paulino, senior vice president of Manufacturing at Amgen. “We continuously invest in our biomanufacturing operations to ensure that we have a reliable and resilient supply (of medicines) for patients.”

“What we are seeing is the union of breathtaking advances in understanding human biology and human disease being united with the tools of tech,” Reese says. “That union is going to propel drug discovery and drug development for the next half century. That's the future.”

Watch Amgen's story as part of Nasdaq’s #InnovationRealized series below.

Amgen Leaders Join the Conversation at Financial Times Global Pharma and Biotech Conference

Tue, 08 Feb 2022 21:03:43 Z

Amgen leaders Gilles Marrache and Greg Friberg took to the stage at the Financial Times global pharmaceutical and biotechnology conference in November, when CEOs, policymakers and thought leaders came together to discuss the future of the industry.

Echoing the overall conference theme of “Sustaining innovation and collaboration beyond the pandemic,” Gilles Marrache (regional general manager for Europe, Latin America, Middle East, Africa and Canada) and Greg Friberg (vice president of Medical Affairs, Europe, Latin-America, Middle East, Africa, Canada) spoke to over 2000 industry professionals on the topics of “Making Pharma more Patient Centric” and the “Power of Partnerships” at this annual event.

Making pharma more patient centric

“The drive for meaningful change for patients challenges us all to work to reorient our healthcare system away from a reactive ‘fixing what’s broken’ model towards a proactive and innovative public health approach aiming to predict and help prevent life-altering events from occurring in the first place,” Marrache told delegates.

Asked how we might achieve this, Marrache commented, “we cannot do this alone. Amgen is partnering with multiple patient-centred organizations around the world, as well as a range of other private and public partners to serve patients.”

Acknowledging the importance of empowering patients, Marrache outlined how Amgen is re-imagining new approaches to support patients “where they are” and constantly looking at innovative ways to engage with patients. “Our ambition is to improve outcomes for patients, identifying and aiming to remove potential roadblocks in the patient journey,” he told the audience.

As an example of reaching patients “where they are,” Marrache described an initiative to offer holistic healthy ageing solutions to help women aged over 65 who live with osteoporosis and hearing loss, connecting with women when they have their regular hearing check-ups. The ambition of this new pilot collaboration with Sonova Group’s Audiological Care business is to increase the diagnosis rate of people at dual risk of fragility fractures and hearing loss in Europe by 30% by 2024, Marrache told the audience. “This means that an additional 160,000 fractures due to osteoporosis could be prevented.”

The power of partnerships

Building on the need for change, Friberg told the audience that COVID has exacerbated the challenges that the healthcare system was already facing, such as increasing prevalence of chronic diseases, health disparities and constrained budgets.

“It’s important that we collaborate to highlight the disruption of care as an unintended consequence of COVID-19 and help ensure that patients from underserved communities and patients with chronic disease are not forgotten,” he noted. “Collectively, we can make a significant difference.”

“At Amgen, we are partnering to drive innovation beyond the molecule and transform care delivery to serve patients. Advances in precise detection and diagnosis will greatly minimize the cost of treating chronic conditions. Harnessing more sophisticated use of remote tools like telehealth and remote patient monitoring, and new knowledge of genome sequencing and molecular diagnostics is offering a better understanding of the precise nature of diseases and ways to develop personalized medicine for treatment and improve outcomes for patients.”

Friberg reiterated the importance of moving from the traditional “one size fits all” approach to more efficient, targeted or personalized treatments. He shared a proof point of how Amgen collaborates with multiple stakeholders in a current initiative bringing together 19 key hospitals, local societies and local governments in the EU to transform cardiovascular outcomes post Myocardial Infarction (MI) care. “We are focusing on patients with high risk of a secondary events via better post MI care pathways and benchmarking of outcomes to drive adherence to guideline therapy and improve patient outcomes,” he advised.

Marrache and Friberg concluded by telling conference delegates that Amgen is committed to acting as a catalyst for change.

Successful Groundbreaking Ceremony for Amgen Ohio

Wed, 02 Feb 2022 23:50:05 Z

At a ceremony last week, Amgen broke ground on its newest manufacturing facility, a 160,000-square-foot final product assembly and packaging plant in Central Ohio, just outside of Columbus. The event was attended by Amgen chairman and CEO Bob Bradway, who grew up in the Columbus area, along with Amgen Ohio site head Sandra Rodriguez-Toledo, and local elected officials and business leaders.

"Although Central Ohio had a bit of a home-field advantage—at least with me—among the dozen-plus locations that Amgen considered for this facility, it's not why we ultimately chose Columbus," Bradway said. "Instead, it was because this area offers advantages that no other region could beat: an attractive and welcoming business climate – a growing and diverse pool of talent – and a convenient, central location that fits well into Amgen's overall manufacturing and distribution network."

Amgen plans to invest $365 million into the site, part of nearly $1 billion Amgen will invest in new manufacturing capacity in the United States, also including a new multi-product drug substance manufacturing facility in North Carolina. Once Amgen Ohio is up and running, the site will bring around 400 new jobs to the local community.

"Amgen Ohio will be a state-of-the-art facility having the latest available digital and robotic technology," Rodriguez-Toledo said at the event. "In addition, it will be an environmentally friendly facility where we will implement technologies designed to reduce energy and water consumption, carbon production, and waste."

Amgen Ohio is expected to be operational by 2024 and will help ensure Amgen continues to provide a reliable supply of its medicines to seriously ill patients.

Every Patient Counts, Every Story Matters

Tue, 08 Feb 2022 21:03:43 Z

In 2016, Jeff Carpenter learned that he had both lung cancer and a brain tumor. Ten days later, doctors successfully removed his brain tumor, but told Jeff that because of his lung cancer he likely only had three to six months to live.

Jeff’s oncologist Dr. Ravi Salgia of City of Hope, gave Jeff the news that his latest PET scan showed no evidence of lung cancer in January 2019. Recently, Jeff and Dr. Salgia reflected on the journey they went through together—from their first meeting in Jeff’s hospital room after his brain surgery to the day he learned he is cancer-free.

“We hold hands to go through this journey together and you truly represent that miracle,” Dr. Salgia said. Their story is part of Every Patient Counts, Every Story Matters – an Amgen sponsorship with the non-profit organization StoryCorps to raise awareness about different types of cancer through the sharing of personal stories.

StoryCorps’ mission is to preserve and share humanity’s stories in order to build connections between people and create a more just and compassionate world. With permission, the conversations that StoryCorps facilitates and record are archived at the Library of Congress.

Amgen and StoryCorps have worked together for more than five years to bring together patients, caregivers, nurses, doctors, and others affected by cancer to reflect on their most poignant moments. Jeff and Dr. Salgia’s story is one of several recorded with City of Hope earlier this year.

November is Lung Cancer Awareness Month—a time when sharing and listening to inspirational stories can help support those in the lung cancer community and raise awareness about the impact of this disease.

Listen to an excerpt of the conversation between Jeff and his doctor below.

To hear more stories, visit Amgen’s Every Patient Counts, Every Story Matters playlist on YouTube and follow Amgen Oncology’s Twitter and LinkedIn channels to stay up to date on our latest.

What to Know About Biologic Medicines for Severe Asthma

Tue, 08 Feb 2022 21:03:45 Z

This educational article was written by Amgen in partnership with the Allergy & Asthma Network, an organization that helps people affected by asthma, allergies and related conditions through outreach, education, advocacy and research.

When most people think of asthma, they envision someone using a rescue inhaler when they feel out of breath, but for many people living with asthma, a rescue inhaler isn’t always enough. This is even more true for people who live with severe asthma.

Asthma is a complex spectrum of diseases, and severe asthma is not the same as the childhood asthma most people are familiar with. People with severe asthma may sometimes not first experience symptoms of illness until adulthood, and their conditions often require comprehensive management plans, including preventive medicines and lifestyle changes beyond the use of inhalers. That’s because, for people with severe asthma, something as simple as the scent of perfume in a department store could be enough to trigger an attack that requires a trip to the hospital.

People living with severe asthma may feel like their condition could remain uncontrolled for the rest of their lives, even with a management plan and taking steps to reduce risks. Imagine having to keep a rescue inhaler within arm’s reach 24 hours a day. Or making dramatic lifestyle changes to control your environment, such as not going outside when the temperature may be particularly warm or cold, taking extra precautions to avoid dust or pollen in your home, or even choosing vacation spots with hospitals nearby in case of unexpected exacerbations.

But treatment options for severe asthma exist, including medications called biologics that may help prevent some attacks for certain people living with severe asthma.

Biologics: Medicines made from living cells

Biologics are a type of medicine made from living cells, proteins such as antibody or gene therapies, many of which represent the cutting edge of medical innovation. Biologics can be powerful therapies because they can be targeted to specific actions in the body for the treatment of many different serious illnesses, including cancer, osteoporosis, and inflammatory diseases like asthma.

Amgen created one of the world’s first biologic medicines in the 1980s, and today the biotech company remains a leader in the innovation, development and manufacturing of biologics across a range of disease types. Understanding the fundamental biological mechanisms of disease is a defining feature of Amgen's discovery research efforts. Amgen scientists are committed to harnessing the power of the human body to combat the most serious illnesses people face.

Asthma is more than just “trouble breathing”

Asthma is a spectrum of chronic, long-term lung disease that is highly individualized, which means that every person living with asthma has their own unique experience that requires a custom treatment plan to manage their condition. Asthma is fundamentally a disease of inflammation, with a trigger such as an allergen, smoke, or a virus causing inflammation in the airways. But it doesn't stop there: When an outside trigger initiates inflammation, it creates a waterfall effect, in which the patient’s own body—the immune system, along with certain cells and chemical signals—creates a cascade of even more inflammation that constricts the airways, making it hard to breathe.

Because each person’s asthma is different, patients can have unique triggers, unique responses to them, and require a personalized mix of therapies to effectively control their condition. Asthma also disproportionally affects Black, Hispanic, and Indigenous Americans due to health disparities, including environmental and economic factors. Scientists are actively working to better understand the causes of asthma and how to better manage it in different patient populations.

How can biologics help with severe asthma?

Biologics for asthma are medicines normally given once or twice a month to help prevent symptoms, rather than treating the symptoms after they occur, and target the cells and pathways that lead to allergic inflammation and breathing problems with asthma.

Biologics can make a big difference for people living with severe asthma, but not every biologic is right for every patient. That’s why it’s so important for people with severe asthma, especially if their disease is uncontrolled, to work with their asthma or allergy specialist to decide which asthma management plan best fits their unique needs – and whether that management plan should include a biologic.

For more information, and suggested questions to ask your doctor at an upcoming appointment, check out the video, Ask the Allergist: Biologics for Severe Asthma, from the Allergy & Asthma Network.

Amgen Named One of the ‘World’s Best Workplaces’

Tue, 19 Oct 2021 20:37:36 Z

Amgen has been named one of the 25 best workplaces in the world by Great Place to Work^®, ranking #8. This is the first time Amgen has made this prestigious list at the global level.

Since 1992, the Great Place to Work organization has surveyed more than 100 million employees globally and these data are used to recognize companies at a global, regional, and national level. The Great Place to Work judges highlighted Amgen’s efforts to keep staff safe and engaged throughout the pandemic, as well as for its ongoing efforts to build a more diverse, inclusive culture. Other companies in the top 25 are 3M, American Express, and Salesforce.

“We are very proud of this honor,” said Bob Bradway, Amgen’s chairman and chief executive officer. “To be recognized by Great Place to Work on a global scale demonstrates our ongoing commitment to providing staff with an environment in which they are able to grow and thrive – even during challenging times.”

Earlier this year, Amgen was ranked as the seventh best workplace in Europe, making the list for the fifth time with its highest ranking ever. Twenty-five Amgen affiliates have either been certified or recognized by Great Place to Work^® nationally. This includes 13 affiliates in Europe, as well as Algeria, Brazil, Colombia, Egypt, Kuwait, Mexico, Morocco, Saudi Arabia, Singapore, South Africa, Turkey and the United Arab Emirates.

“The past 18 months have not been easy,” said Murdo Gordon, executive vice president of Global Commercial Operations. “Many of us have had to adapt to working from home, often with multiple priorities to juggle both personally and professionally. Yet we’ve shown great resilience and a continued commitment to living our values and serving patients. Amgen is a great place because of our great people. Congratulations to everyone!”

Earlier this year, Amgen was named by Forbes as one of “America’s Best Employers for Diversity” for the fourth straight year and also landed on the magazine’s inaugural list of “America’s Best Employers for New Graduates.” Also this year, Amgen earned a perfect score – for the fourth consecutive year – on the Corporate Equality Index, the premier benchmarking report on corporate policies and practices related to lesbian, gay, bisexual, transgender and queer workplace equality.

To learn more about the Great Place to Work “World’s Best Workplaces” list, click here.

Building Healthcare System Resilience With Biosimilars

Tue, 26 Oct 2021 22:46:07 Z

Promoting quality care while managing healthcare spending is one of the greatest challenges facing the U.S. healthcare system—one further exacerbated by the COVID-19 pandemic, which has created significant financial burden for governments, hospitals and patients.

Of the myriad “cost-saving” proposals under consideration, most come with debatable benefits, unknown consequences, and threats to future treatment advances. One approach, however, has shown to effectively bend the cost curve while simultaneously protecting headroom for innovation: fostering competition supported by the introduction of reliably supplied, high-quality biosimilars.

Data from Amgen’s 2021 Biosimilar Trends Report demonstrate that competition supported by biosimilars has the potential to provide cost savings for public and commercial payers.¹ Here’s a closer look at trends shaping the U.S. marketplace with biosimilars.

The U.S. marketplace for biosimilars is well-established, accelerating across multiple therapeutic areas

Since the first biosimilar launched in the U.S. marketplace in 2015, 30 biosimilars have been approved by the FDA and 21 biosimilars have been launched, giving patients and the healthcare system more treatment options and a greater degree of flexibility of choice.² Biosimilars have gained substantial share in the majority of therapeutic areas where they have been introduced,³ with more payers adopting biosimilars, replacing originator products with biosimilars on their formularies, or designating biosimilars as preferred products.^4,5

Biosimilars are contributing to healthcare system resiliency now...

Biosimilars are helping reduce healthcare costs by providing significant Wholesale Acquisition Cost and Average Sales Price savings at launch and through price competition.⁶ As time goes on, competition can lead to declining prices for both reference products and biosimilars, and we can expect to see increased savings for the healthcare system. As a result, the cumulative savings in drug spend for classes with biosimilar competition is estimated to have been $9.8 billion over the past five years in the United States.⁷

...and driving future cost savings and treatment options

This year’s Report features a new section on the future state of the marketplace, including how advancements in biosimilars can support the long-term sustainability of the U.S. healthcare system. So, what does the future have in store?

Biosimilar growth is expected to continue, with competition estimated to triple by 2023,⁸ as the U.S. marketplace sees biosimilars introduced for multiple therapeutic areas, including the potential approval of more interchangeable biosimilars. Anticipated entrants—including two Amgen biosimilar candidates—are expected to significantly impact the autoimmune class, the third largest therapeutic area by non-discounted drug spending. Over the next five years, it is estimated that biosimilars can save the U.S. healthcare system approximately $100 billion.⁹

Promoting a policy environment that facilitates continued success of biosimilars

Further, regulators and policymakers can continue to play an important role in driving understanding, reimbursement, acceptance, and adoption of biosimilars. As we look ahead, policymakers can best nurture a long-term, sustainable marketplace with biosimilars by maintaining effective policies that allow head-to-head competition among reference products and between biosimilars.

Download the latest Biosimilar Trends Report and watch Jen’s video below to learn more about how competition created by biosimilars is contributing to a more resilient healthcare system.

IQVIA (2018). The Impact of Biosimilar Competition in Europe. PDF file. Retrieved from: https://www.medicinesforeurope.com/wp-content/uploads/2017/05/IMS-Biosimilar-2017_V9.pdf
AmerisourceBergen. Biosimilar approval and launch status in US. https://www.xcenda.com/biosimilars-trends-report. Accessed September 2021.
Data on file, Amgen; Biosimilars Market Share Trends; July 2021
Miller S. Cigna continues efforts to lower prescription drug costs by promoting biosimilars. Cigna website. https://www.cigna.com/about-us/newsroom/innovation/cigna-continuesefforts-to-lower-prescription-drug-cost. Published June 2021. Accessed July 19, 2021.
UnitedHealthcare. Medical benefit specialty drug update bulletin. https://www.uhcprovider.com/content/dam/provider/docs/public/resources/news/2020/sdub/medbenefit-specialty-drug-update-bulletin-october-2020.pdf. Published October 2020. Accessed July 19, 2021.
Data on file, Amgen; Product and Biosimilars - WAC and ASP Price; July 2021
Data on file, Amgen; Biosimilars Spend Analysis; July 2021
IQVIA Institute for Human Data Science. The Global Use of Medicine in 2019 and Outlook to 2023. January 29, 2019. URL: https://www.iqvia.com/institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023. Accessed September 2021.
IQVIA. A positive road ahead for biosimilars?. January 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports/a-positive-road-ahead-for-biosimilars.

Amgen’s Third-Longest Tenured Employee Leaves a Legacy After 35 Years of Service

Wed, 02 Feb 2022 23:50:05 Z

Cheryl Meisner remembers when she first started working at Amgen in 1986, a few years before the company would launch its first major drug. It was nothing like the substantial facilities that exist in Southern California today.

“We had four buildings and the one I came to work in was called Building 4 ½ because the leadership didn’t want to hear about planning for a new building because, at the time, we didn’t have the funds,” Meisner said. “Now it’s the PS-2 parking structure.”

Meisner laughed at the memory. Of course, a lot can change over the course of 35 years: A company. A career. A life.

On Oct. 25, Meisner will say goodbye to Amgen as its third-longest tenured employee. She was hired back when Amgen had just a few hundred employees based in Thousand Oaks and its share price was trading well under $1.

In her tenure, she held roles ranging from quality assurance, facilities operations and incident management planning. And she will begin a new chapter of her life – part of which will include visiting her two grown sons in Florida and Texas.

“I haven’t set any dates, but I know it won’t have to be during the July shutdown now,” she said,referencing one of the company's celebrated vacation times for U.S. employees.

For more than three decades with the company, Meisner has been busy. And in the last 18 months at Amgen amid a global pandemic, she’s been really busy.

From H1N1 to COVID-19

When the H1N1 flu hit the United States more than a decade ago, Meisner made some critical decisions that would help Amgen be better prepared for a global pandemic that struck in 2020.

My Lan Tran, who works as senior manager in Environment, Health and Safety, has spent the pandemic working closely with Meisner on the Incident Management Team. She said Meisner always saw things through the long view and that helped Amgen be better prepared.

“When everyone was worrying about that flu, I remember working with her to set up care kits and to make sure we had enough masks and hand sanitizer,” Tran said. “She felt strongly about needing to be prepared and on heightened alert because it could happen again.”

And it did – on such a larger scale.

COVID-19 has touched every nation, killing more than 4.2 million to date since the World Health Organization declared it a global pandemic in March 2020. It has also reshaped the way businesses operate, including Amgen, by making much of the workforce virtual first, with stringent safety measures put in place to return to work and requiring vaccinations in the U.S. and Puerto Rico to minimize risk.

Meisner said working on the incident management team during the pandemic was difficult but rewarding. It gave her a chance to help and protect what she cared about most at Amgen: The people.

Her boss, Narayan Balachandran, said the company will miss her a lot as well.

Balachandran, executive director of engineering at Amgen, said she brought vast, institutional knowledge to the company.

He said her work during the pandemic stood out because she always had a firm handle on risk management and knew how to bring the right people together to tackle the crisis effectively. He said she always brought good information from good sources that helped leadership make good decisions.

And, he said, she always remembered why she was doing what she did.

“She wanted to make sure the scientists could keep doing the science,” he said. “No matter the situation, she put Amgen first and she showed that by always being willing to help others – even if it was not in her area. She was a great collaborator and her attitude was always ‘Let’s get this done so we can deliver to the patients.’”

Early Days, All-in

When she answered the ad in the Thousand Oaks News Chronicle in 1986, she was straight out of college and working summers at Rockwell, the aerospace giant. She met the man who would become her husband while attending Cal Lutheran University. She has a degree in biology and eventually earned her MBA while working at Amgen.

Meisner said Amgen, still a start-up of sorts – looked like a promising and exciting company to hook up with in the mid-1980s. She said biotech seemed innovative and it appealed to her interest in biology, something that began to blossom while attending Thousand Oaks High School.

Things took off in 1989 when Amgen got its first drug approval. The new medicine put Amgen on the map and she remembered how, as a part of the quality assurance team, getting the proper Food and Drug Administration labels and boxing them up felt both exhilarating and overwhelming.

She said the whole company pitched in to help package the medicines, sometimes staying up all night to take the vials, package them and get them delivered. There was a single line of people folding boxes and putting vials in by hand within a small warehouse.

Cheryl Meisner wearing the suit she wore to her interview with Amgen in 1986. Photo courtesy of Cheryl Meisner.

When the FDA labels came and the drugs were shipped out, she felt like they could finally celebrate.

Leslie Chin, who worked with Meisner and has been with Amgen about a year longer than Meisner, said she remembered how the two of them worked together as the company grew into itself. There were early years when Amgen would receive raw materials and the delivery company would just drop them off on pallets in the parking lot. There was no staff to unpack them so Chin and Meisner usually unboxed everything themselves.

“We also didn’t have computers back then and Cheryl had to create labels that we put on every container of material and we would get 1,000 of them,” Chin said. “Because there were no computers – and therefore no printers – Cheryl used to write them by hand: the batch number, the person who created them, the date. Fortunately, she had very neat handwriting – even after doing it a thousand times.”

Chin, who is now a senior specialist in Quality Assurance, said Meisner has left an indelible legacy on Amgen and, even though she is leaving, she also leaves behind a history that helped make Amgen what it is today.

Beyond Amgen

Meisner can reflect on what she’s most proud of during her time at Amgen, including one key contribution during Hurricane Maria where the Puerto Rico manufacturing site was hit by the Category 5 storm in 2017.

She managed to secure a guaranteed fuel contract, which included a foreign fuel service, that helped keep manufacturing running despite the widespread damage caused by the hurricane and ensured patients could get their medicines without interruption.

There have been many other successes, too.

Meisner helped the Incident Management team draft an emergency response to a potentially devastating earthquake that could hit California. She has helped the California sites navigate severe wildfires in recent years and, of course, has been coordinating with sites all over the world to be prepared for all manner of disasters.

In her career, she has worked on several product teams for drugs that went to market and took on key roles in quality in the role of Global Testing Process.

“She has basically seen Amgen from the very early stages to the present. She’s seen so many things,” said Scott Sharts, director of facilities at Thousand Oaks. “She’s always so prepared and pragmatic, but she’s also an emotive and caring person and has always been that way. She’s one of the reasons why I love going back to work and doing what I do – people who make a difference like Cheryl.”

Meisner will leave this month and turn in ID Badge No. 328. It’s the third lowest badge number in the company and only one of only a handful of remaining employees that has one that’s fewer than four digits.

She said she recently purchased an electric bicycle with the help of an employee rewards program and has already taken to riding it around the neighborhood. She wants to visit Portugal for the first time. She still dreams of taking a safari trip at some point in the future.

Cheryl Meisner's original ID badge photo. Photo courtesy of Cheryl Meisner.

But she said she will miss the people she met and worked with along the way at Amgen.

“I love working at Amgen and I put my heart and soul into it,” Meisner said. “Now it’s time to enter a new phase of life and experience different things.”

Discover What Fosters Innovation and Drives Change Through Amgen’s Innovation² Series

Tue, 19 Oct 2021 20:37:36 Z

Where does innovation start and how can creativity grow within an organization? What motivates people to think differently and ultimately change the status quo?

Amgen and The Nation of Artists set out to answer some of these burning questions through a series of virtual conversations called Innovation².

Throughout the series, pioneers in science, technology and business engage in inspiring conversations about innovation and highlight their personal contributions to today’s cutting-edge science and innovation.

New episodes uncover how innovators inspire others and drive change, as well as what motivates them:

Ep 1: Changing a Mindset: Phuong Khanh (PK) Morrow, vice president of Global Development at Amgen, meets with Mike Pell, director of The Microsoft Garage, a program that delivers experiences to employees, customers, and partners that drive collaboration, creativity and experimentation.
Ep 2: Nurturing Innovation: Ray Deshaies, senior vice president of Global Research at Amgen meets with Iranian-born American businesswomen and first Muslim woman to travel into space, Anousheh Ansari, CEO of XPRIZE Foundation, a non-profit organization that designs and hosts public competitions intended to encourage technological development to benefit humanity.
Ep 3: Making an Impact: Cathy Critchlow, vice president of Research and Development Data Strategy at Amgen, meets with Lauryn Nwankpa, Head of Social Impact at Dave, a fintech company helping people to improve their financial health.
Ep 4: It Takes Tenacity: Peter Kufer, vice president and Innovator of BiTE^® Technology at Amgen, meets with David Putrino, Head of Rehabilitation Innovation at Mount Sinai Hospital, a health care system in New York City providing medical care to local and global communities.
Ep 5: A Lesson in Perseverance: Rusty Lipford, director of Inflammation and Oncology Research at Amgen meets with Aaron Horowitz, co-founder & CEO of Sproutel, a patient-centered research and design studio that develops products focused on improving health outcomes.

The first three episodes are also live on The Verge, a multimedia source covering accelerating technological change in ways that are impactful to a broad audience, interested in technology, science, art and culture.

Future episodes coming in 2021 dive into how innovators push against the status quo to make a difference in the world and utilize synchronicity to drive change.

Be on the lookout for episodes featuring Amgen leaders such as:

Synchronicity, a Catalyst: with David Reese, executive vice president of Research and Development at Amgen and James Reese, Former Chief Operations Engineer and "Head Neurosurgeon" at Google
Changing the Status Quo: with Rob Lenz, senior vice president of Global Development at Amgen and Aprille Ericsson, Aerospace Engineer at NASA

The series has already gained award-winning recognition, taking home four Platinum Hermes Creative Awards in the following categories: Documentary, Motion Graphic, YouTube Video and Original Music.

To stay up to date on the latest episodes of Innovation² and to see more from our participants, follow Amgen Oncology’s Twitter and LinkedIn channels and Amgen’s YouTube, Twitter, Facebook, Instagram and LinkedIn channels.

Global Diversity Awareness Month: Our Differences Lead to Better Science

Tue, 19 Oct 2021 20:37:37 Z

Amgen global employees talk about bringing their authentic selves to the workplace, advancing the diversity, inclusion and belonging journey and strengthening the company's culture during tumultuous times.

Throughout Global Diversity Awareness Month, this October, a diverse range of Amgen employees reflect on how the company has made them feel a sense of belonging and discuss their part in helping to create an inclusive workplace. Employees around the world—from Amgen's headquarters in Thousand Oaks, California to locations in Brazil, Canada, Ireland, Puerto Rico, Singapore, South Africa, and more—share their perspectives on topics that range from navigating through the pandemic, to taking a position on uncomfortable high-profile social justice movements, and playing a role in helping drive positive change in and outside of the workplace.

View Amgen leaders and employees sharing their views on the ongoing commitment to build an inclusive culture and serve diverse patients in the video below.

“Green” Chemistry Makes Pharmaceutical Manufacturing Better for the Planet

Tue, 19 Oct 2021 20:37:37 Z

For Sharon Michalak, sustainability and conservation were priorities long before she stepped inside an Amgen lab. But when the synthetic chemist joined the biotech company Amgen in Process Development—where scientists create the chemical processes for manufacturing medicines—she found an opportunity to apply her passion for sustainability on a global scale. That came through puzzling out environmentally friendlier ways to make molecules using what’s known as “green” chemistry.

“I was already eliminating single-use plastics and reducing my individual carbon footprint in my personal life,” explains Michalak, who now serves as the green chemistry lead, and a scientist in Drug Substance Technologies, Pivotal and Commercial Synthetics. “When I came to Amgen and learned about our green chemistry program, I realized that lifestyle changes were well and good, but I could now have a global impact on environmental sustainability by designing green chemistry in my fume hood at Amgen.”

A history of leadership in green chemistry

Green chemistry first gained traction in 1990s with the goal of making products using chemical processes that reduce waste, conserve energy and employ alternatives to hazardous substances. “Any time we’re doing chemistry, we can have a real impact on the environment,” says Oliver Thiel, executive director of Process Development at Amgen. “Green chemistry is fundamentally trying to minimize the impact on the environment from our chemistry. It also nicely combines with economic benefits, because the fewer materials you need, the less waste you generate and the more cost-effective your production processes will be.”

Margaret Faul, vice president of Manufacturing and Clinical Supply at Amgen, was an early advocate for green chemistry in Amgen’s labs, and her pioneering leadership paid off, with Amgen becoming an early member of the Green Chemical Institute Pharmaceutical Round Table and earning industry recognition over the years for its innovative green processes. In 2017, for example, the U.S. Environmental Protection Agency (EPA) awarded Amgen its Green Chemistry Challenge Award for developing, in partnership with Bachem, a green process for the manufacture of one of Amgen’s nephrology medicines a 71% reduction in solvent use, a five-fold increase in throughput, and an estimated 40% reduction in operating time.

“The original process for manufacturing this medicine was wasteful and used a large amount of organic solvent,” Michalak says. “Our process chemists not only made it greener than most other peptide therapeutics made by solid-phase synthesis in the industry, but it also saved Amgen a significant amount of raw materials cost when that process was scaled for global manufacturing.”

Green chemistry in Amgen’s 2027 Environmental Sustainability Plan

While green chemistry has been an important part of process development at Amgen for many years, these efforts have recently returned to the forefront as a key component of the company’s 2027 Environmental Sustainability Plan, which aims to achieve carbon neutrality along with significant reductions in water consumption and waste generation. As part of that sustainability plan, Process Development has launched an active Environmental Sustainability Team, sponsored by Margaret Faul.

Co-authors of a recent review article in the Israel Journal of Chemistry (from left to right): Matt Beaver, Seb Caille, Elcin Icten Gencer, Sharon Michalak, Gabrielle St-Pierre and Oliver Thiel.

Recently a diverse team of scientists and engineers, working at Amgen’s lab sites in both Cambridge, Mass., and Thousand Oaks, Calif., published a review article in the Israel Journal of Chemistry that highlighted real-world examples of work that “contributed to the development of processes that are significantly greener and more environmentally friendly that the corresponding starting points.”

“One key enabler of green chemistry that we are learning and building on is the use of biocatalysis, which employs small quantities of biocatalysts to enable reactions,” Oliver explains, “instead of stoichiometric reactions that use large quantities of potentially hazardous reagents, which then go to waste after the reaction is complete.”

“Biocatalysis allows chemists to use enzymes for specific chemical reactions instead of rare and toxic transition metals,” Michalak adds. “I can replace rare or hazardous materials like palladium, iridium or chromium for an enzyme that can do a similar reaction, sometimes even in water rather than an organic solvent.”

Soon, all chemistry will be green chemistry

Green chemistry has the unique benefit of being a win-win for both business and the environment (as outlined in the table below), which is why the principles of green chemistry extend far beyond Michalak’s team of Amgen scientists. “It’s safe to say that all good process chemistry is green chemistry,” Michalak says, “and all process chemists at Amgen are using green chemistry principles to drive innovation, because efficiency and conservation of resources are simply good for the business.”

Concept	Good for planet	Good for business
Atom economy	Fewer by-products	More value from less material
Minimize solvent use	Less waste, less energy	Higher throughput
Optimize reagents	Recyclable reagents and catalysts minimize volume of chemical needed	Higher efficiency
Convergent synthesis	Increase efficiency, saves energy	Higher efficiency, fewer operations
Reduce energy use	Less pollution from power generation and transport	More efficient processes under milder conditions
Real-time analysis	Reduces exposure or release to environment	Increased throughput and process efficiency, fewer batch failures
Prioritize safety	Non-hazardous materials reduce risk of exposure, release, explosions and fire	Reduced potential harm to workers, and capital equipment

Process chemists and engineers can apply green chemistry principles to redesign “traditional” processes, and they are also in the privileged position to design, develop and implement manufacturing processes for new pharmaceutical products and pipeline molecules.

“The world is seeking to address sustainability issues in terms of clean energy, renewables, water waste and overall waste reduction,” Michalak says. “I would say green chemistry is at the foundation of all these because we deal with atoms and electrons and bonds to literally address these challenges at the molecular level.”

Click here for more information on Amgen’s 2027 Environmental Sustainability plan.

Nina Parker on Breaking the Cycle of Asthma

Thu, 28 Oct 2021 15:18:40 Z

Outdoor adventures, like taking walks in the Hollywood Hills, were always a central part of E! News host Nina Parker’s social life—until she was diagnosed with asthma in late 2019. “Living in LA, everyone is very active, and going for a hike with friends is like getting together for coffee,” Parker says. “But I thought I couldn’t do those things anymore because I felt insecure about huffing and puffing and using an inhaler all the time.”

Looking back, Parker feels like she had put herself into an “asthma box”—a mindset in which she had given up on spending time with friends outdoors because she thought that’s what people with asthma, particularly asthma that can be considered severe, were supposed to do. It wasn’t until she started opening up to family and friends, and worked to find a doctor who helped her establish a management plan for her asthma that she was able to get back to living life more on her own terms.

For many people living with asthma, Parker’s story probably sounds familiar. That’s why Parker has teamed up with Amgen and AstraZeneca to share her story as part of Break The Cycle, a campaign that encourages anyone living with asthma to work to understand their level of control and partner with a doctor to find a management plan that’s right for them. “I’m really excited to spread the word,” she says, “because I think a lot of people feel like they’re living in a box they may not belong in.”

It all starts with a diagnosis

A common misunderstanding about asthma is that it’s a childhood illness, and that people who have asthma just need to use an inhaler once in a while when they feel out of breath. The reality is that asthma is a complex spectrum of diseases caused by inflammation in the airway, and it affects everyone differently.

Parker hadn’t experienced any symptoms of asthma until she was an adult, when she started to feel like her breathing had changed and things that should be easy—like climbing the stairs—became very challenging. “At first, it was something I just lived with,” she says. “But then a couple years ago, I was recording a story for Instagram, and when I played it back, I heard this strange heavy breathing in the background. It took a minute to realize it was me.”

That was when Parker decided she needed to seek a diagnosis for her breathing challenges. “It took a while to figure out exactly what was causing my breathing issues, but I went to see a specialist for a second opinion, and that’s when I learned I had asthma.”

From living in a box to helping to break the asthma cycle

An asthma attack can happen when a trigger, usually some type of airborne particle, like smoke or pollen, gets into the airway, causing the person’s own immune system to kick start a cascade of inflammation that constricts their breathing. These attacks can be severe and can require emergency medical care, so it’s easy to realize the importance of understanding and managing triggers.

But for Parker, giving up on the activities she loved also had unintended consequences for her overall health. “I stopped working out—stopped doing a lot of things—because I thought I couldn't do it with asthma,” she says. “It wasn’t until I got a personal trainer, who also happens to live with asthma, that I understood I could still do many of the things I love as long as I take certain precautions.

Being open and transparent about asthma

One of the realizations Parker gained through her asthma journey is the importance of being open and proactive about what’s going on with her health. “On TV, I’m known for being very open and transparent about my personal life, but when it came to being active with my girlfriends, I felt embarrassed about needing to slow down or use an inhaler,” she says. “What's funny is that after I started talking about my struggles living with asthma, other people in my life opened up about their own experiences with asthma, and it made me feel a lot more comfortable.”

The same goes for her experience with her doctor—the need to open up in order find the right match to understand her diagnosis and come up with a management plan. That’s why Nina is thrilled to be partnering with Amgen and AstraZeneca to tell this story and reach people who may be living with asthma.

To hear more about Nina’s story, and to click through helpful tools and resources to understand and manage asthma, visit BreakTheCycle.com.

Working Together to Improve Public Health Outcomes

Tue, 08 Feb 2022 21:03:45 Z

While the current healthcare model is focused on treating and curing serious illnesses like cancer, heart disease and osteoporosis, Amgen is advocating for a different approach: one aimed at predicting who is at risk and helping to prevent the impact of serious diseases from occurring.

We recently talked to Amgen's chief medical officer, Dr. Darryl Sleep, about why the company champions this approach and how progress towards improving public health can be accelerated by working together with like-minded partners.

Why is prevention important, and what does it mean to focus on predicting and preventing diseases?

I've given this a lot of thought in my three years at Amgen. Essentially it is better to prevent serious illnesses or poor outcomes than try and manage them once they occur.

The first thing we ask with this approach is, “What can we do to identify individuals who are at increased risk for serious illness?” That's the predict part.

Then, “What can we do to intervene early enough to avoid, minimize or eliminate the poor outcomes?” That's the prevent part.

Cardiovascular disease, for example, is the most common health problem among American adults. We know a lot about the risk factors that make individuals more susceptible, such as high cholesterol. We also know a lot can be done first to mitigate those factors and then to intervene early to help prevent poor outcomes, whether it's a heart attack, stroke or hospitalization.

Encouraging and increasing screening to identify the risk factors for severe illness and initiating effective preventive measures early, when treatment is most likely to be effective, can reduce the significant negative impact of these diseases.

Why is a collaborative approach needed to address these public health challenges?

The short answer is no individual or group can do it alone. These are major challenges, and the only way we're going to tackle them effectively is by working together. We all have the shared objectives of reducing the impact of serious illness and improving the wellbeing of our communities, and we all bring different but complementary skills to the table. Collectively, we can make a significant difference.

Can you tell us about some of the collaborative programs that Amgen is involved in?

We have great examples of multi-stakeholder programs that I feel honored to be a part of.

The CDC Foundation’s Alliance for the Million Hearts^®, is working toward preventing 1 million heart attacks and strokes through multiple educational campaigns. In 2020, the CDC Foundation led a public service announcement to spotlight the importance of heart health and seeking medical care during COVID-19. More recently, we joined the Foundation in launching “Start Small. Live Big.” to promote simple steps adults can take to protect their heart health. An upcoming campaign will focus on educating adults at an earlier age when prevention is still possible, particularly those in the African American community who are hardest hit by cardiovascular disease.

Amgen also works with the CDC Foundation on EmPOWERed Health to educate and inspire people to be more proactive about cancer prevention, screening and treatment.

The Susan G. Komen and American Bone Health initiative is another example. This three-year program educates women about their evolving risk for breast cancer, bone loss and fracture and encourages screening.

We also recently launched a pilot program with Quest/Walmart Joint Venture that offers bone density screenings for eligible older adults in stores at no cost. This program integrates prevention into an everyday activity, making screening more accessible.

All of these programs help empower patients so they feel more in control of their health, which means they will be more likely to go for screenings and to engage in shared decision-making with their healthcare teams—both of which can lead to better outcomes.

Why is Amgen committed to this work and what value does Amgen bring to the table?

As an MD and a member of the healthcare community, I feel we have an obligation to improve the lives of the patients who live with the conditions for which we have developed innovative medicines. Treatment with our medicines is an integral part of a broader medical solution for patients, and we also have a role to play in improving health and wellbeing across the board. I take that responsibility very seriously.

Our collaborative efforts focus on the disease areas for which we have a deep expertise. Our role extends beyond financial support for these initiatives to lending this expertise and sharing connections across our networks—from academic and community clinical settings to professional societies and patient advocacy organizations—to help make the biggest possible impact.

True collaboration also requires moving beyond perceived conflicts to recognize we each have something to contribute. We've been able to help break down those barriers through these programs to foster stronger collaborations to the benefit of patients.

What’s your vision of the future based on the possibility of what multi-stakeholder collaborations can bring to the world?

The real value of these programs is to identify the at-risk individuals, increase awareness of their risks and their treatment options and intervene early enough that we’re preventing severe undesirable outcomes. Downstream, this would mean fewer heart attacks, strokes, falls, fractures and emergency room visits as well as decreased occurrences of cancer. That’s the objective. Our work might never be done, but that's a dream worth chasing. It's like the Yorkshire Terrier running after the London bus. You might not ever catch it, but you're never going to stop trying.

A Special Edition of Innovation², brought to you by David and Jim Reese (Brothers²)

Wed, 08 Dec 2021 22:31:31 Z

It's safe to say that family dinners at the Reese household were never boring. Dr. David Reese, executive vice president of Research and Development at Amgen, and his brother Dr. Jim Reese, former Chief Operations Engineer and employee #18 at Google and current advisory board member for Harvard Medical School Department of Biomedical Informatics, recently met up virtually to discuss their upbringing, personal inspirations and motivations as part of the latest installment of Innovation².

In the video, both brothers shared the challenges they faced and overcame in their professional careers. Jim shared stories from his early days at Google, including what it took to scale the site from one room of servers to the behemoth search engine that we know today. Similarly, Dave shared his experience taking on drug development for some of the toughest-to-treat diseases, how memories from his days as a medical oncologist motivates him and what it takes to organize the "highly disciplined and specialized army" it takes to bring a drug to market.

You can view David and Jim's episode below, and the rest of the series is available on Amgen's YouTube channel.

Introducing Undruggable, a New Serial Podcast from Amgen R&D Exploring how Multispecifics can Usher in the Next Wave of Drug Discovery

Wed, 03 Aug 2022 17:57:57 Z

Beginning October 21, Amgen's R&D podcast returns with the new series, Undruggable. Produced in partnership with The Scientist, Undruggable explores the latest wave of innovation, featuring conversations about the new types of multispecific medicines that have the potential to radically alter our concept of how drugs can work and pave the way for new therapies.

While breakthrough discoveries have been made, 85% of disease targets are still considered undruggable, which represents an ongoing barrier to developing medicines for complex diseases like cancer and autoimmune conditions. Undruggable discusses some of the latest advancements enabling scientists to make progress against these challenging diseases.

"We are in an exciting time for drug discovery and development. Once thought to be an insurmountable task, scientists are successfully tackling the problem of undruggable disease targets," said Ray Deshaies, senior vice president of Global Research at Amgen. "I'm thrilled to share these conversations that delve deeper into the ways scientists are designing medicines that go beyond what conventional drugs can accomplish."

Joining Deshaies are leaders from Amgen and premier research institutions discussing topics ranging from the promise of induced proximity platforms to the way DNA encoded libraries help scientists screen billions of molecules to find compounds that interact with tricky targets.

The first episode launches today, and the series continues with a new episode every Thursday through November 18. You can find Undruggable here or by subscribing to The Scientist's series LabTalk on Apple Podcasts, Spotify, Stitcher, Google Podcasts, or wherever you like to listen.

October 21: The Next Wave of Drug Development
Ryan Potts, Ph.D., executive director, Research and head of Induced Proximity Platform at Amgen

October 28: The Biology of PROTACs
Craig Crews, Ph.D., professor of Molecular, Cellular and Developmental Biology, Yale

November 4: Discovery at the DNA Encoded Library
Alex Gouliaev, Ph.D., vice president, Amgen Research Copenhagen

November 11: The Emerging IPP Toolkit
Carolyn Bertozzi, Ph.D., professor of Chemistry, Stanford

November 18: Induced Proximity: Reason for Optimism in Treating Cancer and Beyond
David Reese, M.D., executive vice president, Research and Development, Amgen

In addition to the podcast series, Amgen and The Scientist will host three live webinars digging deeper into the science behind the latest technologies aimed at treating undruggable diseases. Register to listen here.

Undruggable is the second of two serial podcasts in partnership with The Scientist. In the first series, DNA Unlocked, host Ray Deshaies takes listeners on a journey Amgen scientists and others have been on for the past 20 years to reveal the promise in the explosion of genome sequencing data to better understand human biology and transform drug research and development, and cure diseases. You can listen to the series here.

20 Years Later and the Pain of 9/11 Still Feels Raw

Fri, 10 Sep 2021 16:28:42 Z

John Menchaca was 30 when he got sick from a liver infection and remembered how his older sister, Dora Menchaca, took it upon herself to contact the public health department in Los Angeles County to begin tracing the source of his illness.

It was Hepatitis-A. He had gotten it from a place he had eaten in Mexico. He remembered more about how determined she was to track the source of the infection than he did about how sick he was then.

“Science and research wasn’t just a profession or a job to her,” he said. “She was all in from the beginning.”

With the Covid-19 pandemic having its grip on the world for more than a year-and-a-half now, Menchaca thinks about what his sister might be doing about that today. He said he imagines she’d be on the front lines of trying to understand and explain the science behind the virus. He can almost hear her talking about how exciting the vaccines were and how she’d be urging the importance of social distancing and mask-wearing.

And then he starts to get choked up because, even 20 years later, the death of his sister remains raw.

Dora Menchaca was 45 when she boarded American Airlines Flight 77 headed from Washington D.C. to Los Angeles the morning of Sept. 11, 2001. He said she was supposed to land that day and see her husband, Earl Dorsey and their two children, Imani and Jaryd.

But like nearly 3,000 others on that day, she never made it home.

Instead, John said all he has now are photos and a tribute binder he can’t quite bring himself to put together. He relies mostly on his memories of her now. But while the nation remembers collectively the tragedy of 9/11, John said he remembers Dora every day.

“She still comes up in conversations all the time with my family,” he said. “Something always seems to bring her to mind.”

And he is reminded again how much he misses her.

Menchaca family 1999 (R to L) John Menchaca, Dora Menchaca, Ignacia Menchaca (mother), Jose Menchaca Sr. (father) Jacqueline Menchaca and Jose Menchaca Jr. Photo courtesy of John Menchaca.

Growing Up

John Menchaca was four years younger than Dora, but he remembered growing up in San Antonio with her and how she was always there to help him with his studies. Education was a premium ideal growing up in the Menchaca family.

“She was a voracious reader. Constantly reading,” he said. “Not just textbooks, either. Every Sunday, her and my dad would sit and go through the entire newspaper in San Antonio – front to back – and discuss what was going on for two or three hours. She had this inquisitive mind and was incredibly curious.”

He said he remembered her being patient with him while helping with his math homework. He said it was no surprise to anyone that as she went through high school, she was going to college. Menchaca said she was always a high achiever and when she was accepted to the University of Notre Dame, the whole family drove up with her in an old Volkswagen bus to see her off.

Menchaca said it was the first time they’d ever been outside the state of Texas.

“I remember when we crossed the Mississippi and it took us by surprise at how big it was,” he said. “We thought the bridge would never end.”

The drive back after dropping her off felt longer. He missed her. But, he said, they drove up again for her graduation from the University of Notre Dame in 1977 and their parents were proud. So was her younger brother, who could see she was on her way to bigger things.

Staying Close

Even as their careers diverged – she went on to the University of North Carolina for her master’s in public health and then UCLA for a doctorate in epidemiology and he was studying to become an accountant – they stayed close.

In the early 1980s, the two shared an apartment together in West Los Angeles while she was still at UCLA and when she gave birth to Imani, he said he got to spend time with his niece while in that apartment. She completed her doctorate in 1986, according to the UCLA Daily Bruin.

John Menchaca with sister Dora Menchaca in 1983 at USC. Photo courtesy of John Menchaca.

The time in the apartment, he said, was filled with great memories. She had plants in the apartment – a foreshadowing of a gardening hobby she would continue at her home in Santa Monica. John mostly recalled how she seemed to balance so much with patience and grace.

He didn’t know it at the time, but he said at a memorial for Dora after the 9/11 tragedy, a woman approached him. She told him about how Dora had played soccer with a bunch of guys and that when one of the player’s wives had gotten ill, Dora wrote the husband a letter in Spanish and sent coupons to restaurants and supermarkets.

“The woman told me Dora gave the gift of time,” he said. “Instead of wasting time running around to stores and restaurants, that time could be spent with his sick wife.”

When John Menchaca got married in 1987, he said Dora's daughter was the flower girl at the wedding. After Dora married, he would visit his sister in Santa Monica. He said his two older daughters would visit “Aunt Dora” and always had a good time with her.

He said she was always great with his children – and especially with hers.

“She would be proud of them,” he said. “They’re both good quality people. Very caring and very responsible and very in touch with life. They took up professions that are meaningful and are going to help humanity.”

Moment Frozen in Time

Dora Menchaca worked hard at Amgen as a director of clinical research and had this inner drive to research a cure for cancer. Her father had been diagnosed with prostate cancer and she was relentless in her pursuit of finding a cure to help those with similar illnesses.

Dora Menchaca was in Washington D.C. briefing U.S. Food and Drug Administration officials on some cancer research the day before on Sept. 10. But John Menchaca said she had been talking about wanting to spend more time with her family and so she caught an earlier flight home on the morning of Sept. 11, 2001.

It was American Airlines Flight 77.

John Menchaca said he can still remember everything about that morning. He woke up and both he and his wife watched in disbelief as the smoke poured from the World Trade Center. He said he remembered talk of Los Angeles being a possible target and how he was going to get to the office to make sure everyone there was OK.

“I hadn’t sat down two minutes and my phone rang,” he said. “It was my dad and he says right away he’s got some bad news; Dora was on one of the planes. He started crying.”

The world shifted at that point for John Menchaca. His sister was dead at 45. The pain that began that day would never really leave.

A year after the attacks, he went to a memorial at Amgen and saw the marker that honors her. Five years after the attacks, he turned 46 – one year past his older sister’s final age. Ten years after, he was going to several memorials for 9/11 victims. Last year, because of COVID-19, he stayed at home with his family – something for which he believes she would have advocated.

But 20 years seems like a long time ago and, alternately, not long ago at all. And for John Menchaca, it’s a moment frozen in time, thawed by grief and scarred forever.

Amgen Celebrates 20 Years of Aranesp^® (darbepoetin alfa) as a Treatment for Patients With Chronic Kidney Disease

Fri, 17 Sep 2021 22:02:59 Z

On September 17, 2001, the vision of one Amgen team was realized with the FDA approval of Aranesp^® for treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis.²

Steve Elliott, PhD, one of the key scientists involved in the development of Aranesp^®, and a retired member of the Amgen team, shared how his team worked tirelessly to develop the treatment. However, behind those long hours was a team passionate about bringing a therapy to market that would make a difference in patients' lives.

The development of Aranesp^® began shortly after the launch of EPOGEN^® (epoetin alfa), Amgen's treatment for anemia due to CKD in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. Following this launch, the EPOGEN^® team continued to study anemia which led to the discovery, development, and eventually the launch of Aranesp^®, a molecule with a longer half-life, which allows for reduced dosing frequency for CKD patients on dialysis and not on dialysis.²

"The team behind Aranesp^® was motivated by an unmet patient need for a longer-acting preparation that would greatly impact patients' lives as it could be taken less often than earlier ESAs," said Dr. Jeff Petersen, Clinical Research medical director in Nephrology at Amgen. ESAs (erythropoiesis-stimulating agents) are medications which stimulate the bone marrow to make red blood cells. "It could help patients not on dialysis, along with pediatric patients which was a very big deal, and the fact that Amgen funded this research is a testament to the passion of the organization behind the product and the knowledge of its immense value for patients."

Since its approval over 20 years ago, Amgen has continued to further develop Aranesp^® while staying true to our original mission of impacting patients' lives.

"The original manufacturing process was developed with safety in mind and the risk-benefit profile of ESAs is well-characterized," said Jim Gardner, global director, Operations at Amgen. "Although this process has evolved over the past 20 years and has been adapted to patients' needs, we have still maintained the same product with regards to safety and efficacy and continue to serve more and more patients."

"But perhaps what makes Aranesp^® so special is the people behind it," Gardner added. "Like me, many other Amgen team members have been involved with Aranesp^® since its launch and feel a real connection to this treatment and Amgen's roots. These teams are very motivated with a patients-first approach."

Thanks to the hard work and dedication of thousands of Amgen employees, Aranesp^® has been received by over seven million patients³,* across 62 countries, and has been studied in more than 19,000 patients during nephrology clinical trials.⁴ In fact, between April 2008 and December 2020, more than 290 million units of Amgen ESAs were distributed in the United States.⁵

Amgen is paving the way as a leader in the development of innovative treatments, with a passion to best serve patients, and the approval of EPOGEN^® and Aranesp^® are examples of this pioneering spirit in the field of anemia due to CKD.⁶

To learn more about Aranesp^®, go to Aranesp.com

Indications
Aranesp^® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

EPOGEN^® (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion.

Limitations of Use:

Aranesp^® and EPOGEN^® have not been shown to improve quality of life, fatigue, or patient well-being.
Aranesp^® and EPOGEN^® are not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Important Safety Information, including Boxed WARNINGS

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
Use the lowest Aranesp^® or EPOGEN^® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
Use the lowest dose to avoid RBC transfusion.
Use ESAs only for anemia from myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.

Perisurgery (EPOGEN^®):

Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.

Aranesp^® (darbepoetin alfa) and EPOGEN^® (epoetin alfa) are contraindicated in patients with:

Uncontrolled hypertension
Pure red cell aplasia (PRCA) that begins after treatment with Aranesp^®, EPOGEN^®, or other erythropoietin protein drugs
Serious allergic reactions to Aranesp^® or EPOGEN^®

EPOGEN^® from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.
Use caution in patients with coexistent cardiovascular disease and stroke.
Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
Control hypertension prior to initiating and during treatment with Aranesp^® or EPOGEN^®.
Aranesp^® and EPOGEN^® increase the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
For lack or loss of hemoglobin response to Aranesp^® or EPOGEN^®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp^® or EPOGEN^®.

This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp^® and EPOGEN^® are not approved).
If severe anemia and low reticulocyte count develop during treatment with Aranesp^® or EPOGEN^®, withhold Aranesp^® or EPOGEN^® and evaluate patients for neutralizing antibodies to erythropoietin.
Permanently discontinue Aranesp^® or EPOGEN^® in patients who develop PRCA following treatment with Aranesp^®, EPOGEN^®, or other erythropoietin protein drugs. Do not switch patients to other ESAs.

Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp^® or EPOGEN^®. Immediately and permanently discontinue Aranesp^® or EPOGEN^® if a serious allergic reaction occurs.
Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp^® and EPOGEN^®) in the postmarketing setting. Discontinue Aranesp^® or EPOGEN^® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
Serious and fatal reactions including "gasping syndrome" can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN^® multiple-dose vials. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively.
Adverse reactions (≥ 10%) in Aranesp^® clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.
Adverse reactions (≥ 5%) in EPOGEN^® clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.

Please see Aranesp^® full Prescribing Information and EPOGEN^® full Prescribing Information

*In the postmarketing setting from launch through December 31, 2020, the number of patients exposed is based on sales revenues data and includes both nephrology and oncology patients.

REFERENCES

ARANESP^® (darbepoetin alfa) FDA approval letter. September 17, 2001.
Aranesp^® (darbepoetin alfa) prescribing information, January 2019. Amgen.
Data on file, Amgen; [ARANESP^® Patient Years; 2021].
Data on file, Amgen; [ARANESP^® (darbepoetin alfa) Periodic Benefit-Risk Evaluation Report; Jan. 12, 2021].
Data on file, Amgen; [ESA Units; 2021].
Q2 RealTime Dynamix: Renal Anemia Report. 2021.

Amgen Joins International Respiratory Coalition as Founding Member

Mon, 20 Sep 2021 18:49:45 Z

Nearly 600 million people globally live with chronic respiratory diseases like asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis as well as many rare and severe respiratory diseases.¹ And each year, approximately four million premature deaths are attributed to chronic respiratory diseases.² Prior to the pandemic, progress to improve chronic respiratory diseases care was slow, and in some countries had stagnated over the past decade.³

During the pandemic, some patients with chronic respiratory diseases that contracted COVID-19 were shown to be at greater risk of hospitalization.^4,5 And patients with chronic respiratory diseases faced disruptions to healthcare services and quality care⁶, demonstrating that new approaches to enable patients to better control their condition, reduce hospitalizations, and ultimately to decrease pressure on healthcare systems, are needed.⁷

The COVID-19 pandemic has exposed fault lines in health systems as well as demonstrated that underlying chronic conditions have greatly contributed to lowered health in populations. During a recent symposium at the European Respiratory Society International Congress (ERS), a multi-disciplinary panel discussed our passion and bias toward action. We must seek to maximize health and outcomes in chronic diseases in particular, to ensure that individuals, and therefore populations, have the greatest possible resiliency against future health shocks.

— Garnet Howells, global product general manager at Amgen

The European Respiratory Society (ERS), the Global Allergy and Airways Patient Platform (GAAPP), AstraZeneca, Amgen and leading respiratory clinicians have launched the International Respiratory Coalition, a new partnership to transform post-pandemic respiratory healthcare. Each partner will provide funding or contributions of time and expertise to deliver the aims of the Coalition at a global or national level.

The Coalition aims to support governments and healthcare systems in their recovery from COVID-19 by strengthening respiratory care. The Coalition will seek to improve outcomes for people living with respiratory diseases by supporting the creation of ambitious national-level respiratory strategies and by building resilience in managing pandemics by implementing a multi-stakeholder, collaborative approach to working with governments.

“COVID-19 is the third respiratory-driven pandemic in just 20 years, which only deepens the urgency to prioritize respiratory diseases in health care systems across the globe,” said Susan Sweeney, senior vice president, Global Marketing, Access & Capabilities. “The statistics are staggering with 1 in 5 hospitalized COVID-19 patients requiring additional respiratory care or rehabilitation, according to early estimates. Another pandemic has the potential for catastrophic impact, so we must work together to prepare for the next health crisis.”

“While COVID-19 exposed the staggering health disparities and disproportionate burden on racial and ethnic minorities and other groups historically underserved by healthcare systems, these same communities have long felt the negative impact of respiratory disease,” said Darryl Sleep, senior vice president, Global Medical and Chief Medical Officer of Amgen. “This partnership with the International Respiratory Coalition will help Amgen in our mission to serve patients, which includes working within communities to remove the barriers that prevent patients from living their healthiest lives.”

For more information, visit the International Respiratory Coalition.

References

GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med, 2020 Jun;8(6):585-596.
Forum of International Respiratory Societies. The Global Impact of Respiratory Disease – Second Edition. Sheffield, European Respiratory Society, 2017. Available online via https://www.who.int/gard/publications/The_Global_Impact_of_Respiratory_Disease.pdf. Accessed July 2021.
Commissions from the Lancet journals. After asthma: redefining airways diseases. After asthma: redefining airways diseases (thelancet.com). 12 September 2017. Available at: https://www.thelancet.com/commissions/asthma.
Gerayeli FV, et al. COPD and the risk of poor outcomes in COVID-19: A systematic review and meta-analysis. EClinicalMedicine. 2021; 33: 100789.
Huang BZ, et al. Asthma Disease Status, COPD, and COVID-19 Severity in a Large Multiethnic Population. J Allergy Clin Immunol Pract. 2021. https://doi.org/10.1016/j.jaip.2021.07.030
World Health Organisation. COVID-19 and NCDs. Available at: https://cdn.who.int/media/docs/default-source/ncds/ncd-covid-19/for-web---rapid-assessment---29-may-2020-(cleared)_125bf384-9333-40c9-aab2-c0ecafb76ab2.pdf?sfvrsn=6296324c_20. Accessed August 2021.
AstraZeneca. A Blueprint for Change. Available at: http://www3.weforum.org/docs/WEF_Blueprint_for_change_Chronic_airway_disease.pdf. Accessed August 2021.

Diversity, Inclusion and Belonging at Amgen – A Progress Report

Wed, 29 Sep 2021 16:17:38 Z

The horrific murder of George Floyd in May 2020 served as a catalyst for many companies – Amgen included – to redouble their efforts to build a more just and equitable society. Since then, Amgen has been working on two tracks – one focused on how to create a more diverse and inclusive workplace within the company, the other focused on how to make a positive difference in the communities where employees live and work. While there is still much work to do, here are seven examples of the progress Amgen has made.

1. Building a team focused on Diversity, Inclusion and Belonging—with new goals for all leaders

In January 2020, Amgen created a dedicated team at the enterprise level dedicated to diversity, inclusion, and belonging (DI&B). Amgen has since added full-time DI&B leaders within its business units, as well as at the regional level around the world. Additionally, more than 90% of Amgen’s top 550 leaders across the company have created personal DI&B action plans.

“The key tenets of my plan are to be curious to understand others and create safe spaces for feedback exchange,” said Haresh Patel, shown at right, who leads the Amgen Capability Center in Tampa, Florida. For example, Patel purposely leaves additional time for feedback during roundtable discussions to engage all participants, including those who appear less comfortable sharing their insights.

Haresh Patel leads the Amgen Capability Center in Tampa, Florida

2. Growing employee resource groups

More than 9,500 Amgen staff (about 40% of all employees) belong to one of the company’s 11 employee resource groups (ERGs), with participation up 6% in the first half of 2021. These ERGs help Amgen employees navigate shared personal and professional challenges, while also providing opportunities to contribute to Amgen’s business and the community. As an example, the Amgen Black Employee Network (ABEN) worked with the Amgen Foundation in 2020 to determine how best to distribute $7.5 million in grants focused on social justice. The Foundation plans to commit another $2.5 million in 2021.

Each of Amgen’s ERGs is sponsored by a senior leader who reports directly to our CEO Bob Bradway. Hear from many of Amgen’s ERG leaders and their executive sponsors through the company’s “Candid Conversations” video series:

Amgen Black Employee Network
Women Empowered to Be Exceptional
Amgen Asian Association
Amgen PRIDE – LGBTQ and Allies Network (PRIDE)
Amgen Early Career Professionals

3. Creating greater awareness through training and education

As of August 31 of this year, 100% of our U.S., Canada and Puerto employees and 98% of global staff* have completed mandatory unconscious bias training, with nearly 90% of staff who responded to a post-training survey agreeing that “as a result of this course, I am aware of concrete actions I will take to mitigate unconscious bias at Amgen.” We also offer employees a wealth of educational resources that they can access online at their own pace.

* Unconscious Bias training is recommended, but not required, for our staff members in Spain, the Netherlands, Italy, France and Germany per guidance from the EU Works Council.

4. Focusing on career advancement, recruiting and equitable treatment

Amgen is placing a particular focus on improving female representation at leadership levels and Black representation at all levels of the organization. Through the first six months of the year, Amgen saw a nearly 25% increase in women at the vice president level, a six-fold increase in Blacks at the VP level, and a more than 40% increase in Blacks at the director level. All told, Amgen was able to fill almost 400 jobs with diverse staff members in the first half of 2021 thanks, in part, to expanded partnerships with new recruiting firms. Please visit the Amgen Careers site to learn more about career opportunities.

To increase the pipeline of diverse future talent, we recently established the Amgen Educational Fellowship at Howard University, one of the country’s leading historically black universities. “My goal is to help my community and to help humanity,” says Pilar O’Neal, one of the first students in the program. The Amgen Foundation also sponsors several science education programs aimed at inspiring future innovators, including LabXchange, a free online platform that provides millions of users with access to personalized STEM instruction, virtual lab experiences and networking opportunities across the global scientific community.

5. Setting new supplier diversity goals and criteria for site selection

Amgen has set a goal to double its spend with diverse suppliers in the U.S. and triple its spend with Black-owned businesses by 2023. Additionally, Amgen will soon break ground on two new manufacturing facilities in the United States – one near Columbus, Ohio, the other in the Raleigh-Durham area of North Carolina. Both of these sites were selected in part because they offer access to diverse talent – consistent with our participation in OneTen, a coalition of leading companies that aims to hire one million Black Americans into family-sustaining jobs over the next ten years. As a member of OneTen, Amgen is also taking a leadership role in the greater Los Angeles region, where the company is headquartered, to help expand the coalition of businesses that share our desire to offer greater opportunities to diverse talent.

6. Improving health equity

In April, Amgen hosted its eighth annual Health Equity Summit, bringing together company leaders, elected officials, patient advocates, and health care technologists in a collaborative effort to advance racial equity in health care. One area of particular interest is improving the diversity of participants in clinical trials, who currently skew dramatically toward white patients. In 2018, Amgen provided $2 million to the Lazarex Cancer Foundation to create a new program to enhance access to clinical trials for cancer patients of all socio-economic backgrounds in the U.S. More recently, the company has committed to increasing the diversity of its own clinical trials in oncology and other disease areas, an initiative first led by Amgen’s Black Employee Network (ABEN). “Our mission is to serve patients and to do that genuinely means reducing barrier to participation in our clinical trials,” says Racquel Racadio, a member of ABEN and the Amgen Asian Association (AAA) who works in our R&D organization and has been instrumental in this effort. “I’m encouraged by the progress we’re making.”

Racquel Racadio, a member of ABEN and the Amgen Asian Association (AAA) who works in R&D

7. Emphasizing personal well-being and mental health

These are challenging times and the company has responded with more than 20 programs focused on mental health and wellbeing in communities of color, as well on the unique pandemic-related challenges facing parents generally and women specifically. Additionally, the company has updated its Business Conduct Hotline and Global Security protocol to encourage staff to report hate-based incidents they may experience in their communities.

“Amgen believes that our differences will lead to better science,” says Tamika Jean-Baptiste, vice president and chief diversity officer of Amgen. “I’m grateful to all Amgen employees around the world who have embraced this idea and are working to make it a reality.”

Inside Amgen's “Virtual-First” Approach to Work

Wed, 15 Sep 2021 22:48:52 Z

Like many companies managing the impacts from the COVID-19 pandemic, a significant portion of Amgen employees began working from home in March 2020. Amgen CEO Bob Bradway recently sent a letter to employees explaining that, “after much reflection on the many lessons learned over the past year, we have decided that most site-based staff working from home today will continue to work from home for the majority of their time – even after the pandemic has ended.” The decision was supported by internal surveys showing that more than 80% of employees working virtually wanted to maintain that flexibility in the future.

This was a pivotal moment, an opportunity to reimagine the future of working at Amgen. The goal: empower a global workforce to work when and where they are most productive, while also providing the flexibility to achieve work-life balance. The priority for Amgen is to find the right balance of virtual and in-person work with the goal of delivering the best outcomes for individuals, teams and patients. The company will also continue to prioritize the safety of its employees and their families, which means that appropriate restrictions for on-site visitation and off-site meetings will be continually examined. Amgen has also required COVID-19 vaccination in the U.S. and Puerto Rico.

Generally speaking, this new approach indentifies work arrangements falling into one of three categories:

Working as “Flexible Commuters”

“Flexible Commuters” are employees who primarily work virtually, but still have the opportunity to come to the office for work that benefits significantly from being face-to-face (such as for team meetings or to collaborate on projects). As these people may still need to come to a site or office occasionally, they should still live within a commutable distance of their Amgen site, and within their existing work country. Most Amgen employees who had been working virtually throughout the pandemic are continuing to operate with this “virtual first” mindset, as will new hires who fall into this category.

Working Remotely

The shift to a “virtual first” way of working has created expanded opportunities for existing employees to become fully remote should they wish to move to a different location if they choose to do so (beyond a commutable distance from their designated Amgen site, but still within their existing work country). The company also remains open to remote work opportunities for potential employees.

Working Primarily Onsite

A select group of Amgen employees who work in laboratories, manufacturing facilities, and other areas have been working onsite throughout the pandemic, following comprehensive safety measures. The kind of work they do requires them to be on-site regularly. As safety conditions permit, site access will be expanded to include additional employees who could benefit from access to onsite equipment, technology and workspaces. While Amgen’s facilities and office spaces around the world will continue to be part of the company’s culture, the company will also preserve what has been learned throughout the pandemic by offering flexibility to onsite employees for activities that may be best completed virtually.

We want to be intentional about where, when, how, and why we come together, rather than simply defaulting back to the old way of doing things. We will continue to invest in maintaining the vital culture and social architecture that has been, and will continue to be, critical to our shared success.

— Bob Bradway, Amgen CEO

Margaret Chu-Moyer Honored with Prestigious Portoghese Lectureship

Tue, 21 Sep 2021 15:25:56 Z

When Margaret Chu-Moyer was still in high school, her natural curiosity started her down a road that would lead to a love of chemistry. "I'd see all these long scientific words on shampoo bottles or toothpaste tubes, and I wanted to know what they meant. Or I'd wonder why my fever would go away when I took aspirin. What was really going on? That's what fascinated me."

That same interest in the power that chemistry has to shape biology has driven Chu-Moyer's career for nearly three decades. It propelled her to her current role as a vice president in Amgen's Global Research organization, and more recently to one of her field's top honors—the Philip S. Portoghese Lectureship.

The medicinal chemistry community is actually quite small, so I knew some of the past recipients of the lectureship. It's nice to have more industry representation on the list, so I'm really pleased about that.

— Margaret Chu-Moyer, vice president Global Research

The lectureship is awarded jointly by the Medicinal Chemistry Division of the American Chemical Society (ACS) and the Journal of Medicinal Chemistry. Named for the journal's long-time editor, it recognizes individuals who have had a major impact on medicinal chemistry research. Chu-Moyer delivered the prestigious lecture on August 24, 2021, at the fall meeting of the ACS.

Chu-Moyer is the 11th recipient of the lectureship, the second woman, and the second chemist based in industry versus academia. "The medicinal chemistry community is actually quite small, so I knew some of the past recipients of the lectureship. It's nice to have more industry representation on the list, so I'm really pleased about that."

A two-fold challenge

Chu-Moyer found her way into chemistry after a brief flirtation with a related field. "I initially thought I wanted to be a pharmacist, because that's where you go to get medicine, and I even volunteered at a pharmacy. But one day when I was counting pills, I realized this wasn't the career I was looking for. I wanted to know how the drug was working. No one had told me that was pharmacology, not pharmacy."

After finishing her undergraduate work at UC Berkeley, she spent a couple of years as a laboratory technician at Abbott to see if she enjoyed the daily work of medicinal chemists. She did, so she completed her formal education by getting a Ph.D. in organic chemistry from Yale. From there, it was on to Pfizer, where she stayed for 16 years, rising to the level of senior director.

"At the start of my career, the big challenge for me was 'How do we make these molecules?'" Chu Moyer recalls. "We still can't make everything we'd like to make, but now I'm much more interested in what we should make rather than how to do it. It's more about the design of the molecule and what different parts of the molecule need to look like in order to make a viable drug."

It's a two-fold challenge, she observed. "First, you need to noodle around with the structure of the compound to make it very specific for your target protein, so that it binds to the target you want but not everything else. Second, you need to ensure that the molecule's properties are pharmaceutically suitable." Suitability encompasses attributes like bioavailability, so the pill isn't too big, and stability to provide an adequate shelf life. You also want a compound that can be manufactured in a robust and environmentally friendly manner, and one that stays in the body long enough to facilitate daily dosing for patients.

Discover makes it sounds like we found something that was already there, but that's not the case. We're inventing new molecules that have never been known to exist before.

— Margaret Chu-Moyer, vice president Global Research

"Sometimes, it's harder to get the right pharmaceutical properties than right interaction with the target," Chu-Moyer observed. "When I started my career, we didn't have good assays to predict these attributes. If you tested the drug and it didn't work well, it was hard to figure out why it wasn't working. Was it because it didn't get absorbed from the stomach into the blood, or because it got metabolized too quickly? We just didn't know. Now we have more techniques we can use to characterize how a molecule needs to bind in its pocket and what we need to do to overcome imperfections and invent the right molecule."

Chu-Moyer has come to prefer that word invent over other often-used terms like identify or discover. "Discover makes it sounds like we found something that was already there, but that's not the case. We're inventing new molecules that have never been known to exist before. We're actually saying, 'This atom should go here and that atom should go over there,' and we understand exactly why the different atoms need to go where we put them."

Large molecules vs. small molecules

In 2009, when Chu-Moyer departed Pfizer to work for Amgen, the move was a bit like stepping from one side of a yin-and-yang symbol to the other. On the one side, Pfizer had a long history in small molecules and was just starting to develop biologic therapies. On the other side, Amgen was a biotech pioneer that was seeking to expand into small molecules to pursue targets inside the cell that aren't accessible to large molecules. Each company had particular strengths arising from its core expertise, and Chu-Moyer welcomed the chance to marry these strengths by coming to Amgen.

"There was a very high structural biology mindset at Amgen," she observed. "The scientists here are world-class in using structure-based design to enhance drug potency. But when I arrived, Amgen was still learning how to build more drug-like properties into its small molecules. That was knowledge I could contribute."

Large molecules such as antibodies typically originate in humanized lab mice and are manufactured in living cells. "A molecule derived from an animal already comes with many of the properties needed to function well in a living system," Chu-Moyer observed. Scientists still need to identify and optimize the best antibodies to create the right medicine, but large molecules tend to start this journey closer to the finish line than chemical compounds.

"With small molecules, the hits you identify through screening usually need a hundred-fold or a thousand-fold improvements, so it's a lot of work," said Chu-Moyer. "There are hundreds of criteria that we are trying to maintain or improve, so it's a real balancing act to design and select the best overall molecule. Sometimes I'm amazed that we can actually arrive at a molecule that can meet the majority of our criteria."

In her Portoghese lecture, Chu-Moyer drew on Amgen's experience and lessons learned in designing a small molecule inhibitor of KRAS G12C, a hard-to-drug mutation found in several cancers.

"I talked about the importance of really understanding how you want to tinker with the protein target. I wanted to focus on that because, when I was a young medicinal chemist, it was all about the structure-and-activity relationship. 'Just show me the molecule, and I'll figure out how to make it more potent.' I didn't think enough about what the protein was actually doing, how it worked, and therefore mechanistically, how are you going to inhibit it. I think that's more important today because we have more tools in our box."

Taking Time Off to Honor a Loved One (at Altitudes of 13,000 Feet)

Fri, 17 Sep 2021 04:04:56 Z

This is part two of a story about Suzanne's journey. See the original story here. Suzanne's story was a part of her participation in the Dempsey Challenge, a partnership between Amgen and the Dempsey Center.

Her son was sick, the storm clouds were menacing and Suzanne Towry's body ached. Mount Whitney loomed in the distance – the prize peak that she so desperately wanted to summit.

But things weren't going to plan three days into their 12-day hike along California's John Muir Trail. Tough decisions had to be made.

They could try and scale it, but the risks were two-fold: Get caught by a menacing storm or further exacerbate her son's Acute Mountain Sickness (AMS) that had been developing since the day before. Towry, who works in Learning and Development at Amgen and had years of search and rescue experience, knew both problems could prove fatal on an unforgiving mountain. Three hikers had to be rescued from the mountain the day they were supposed to summit.

She thought about what her husband might do in the moment.

Suzanne Towry brought ashes of her husband, Emile "Knute" Pourroy along with her on the hike of the John Muir Trail. This was taken along the Bubbs Creek Trail. Photo: Suzanne Towry

Emile "Knute" Pourroy was always the lead hiker and backpacker when they went out on the trails together. They had met as search and rescue team members; both shared a love of the outdoors, but she now realized she had relied on him more than she thought.

When cancer claimed him in October 2019 – a few years before the two of them had planned the ultimate hike along the John Muir Trail – she decided to hike it in his memory and bring his ashes along. It would be the fulfillment of a dream they had bonded over together. Mount Whitney would have been great to summit, but it wasn't the reason they were there.

Towry and her son decided to circumvent it. They still had about 10 more days and over 150 miles to go, climbing over several passes that would top over 13,000 feet. Besides, Mount Whitney wasn't going anywhere. She could try again another time.

"The longest hike I ever did with Knute was 28 miles in six days," she said. "This was going to totally surpass my record. It was going to be hard, but this was going to be a long journey in many ways anyway and I think Knute knew that."

First Days

The first steps toward the John Muir Trail were joyous. Surreal, too.

"I hadn't been backpacking on a long, hard trip without my husband and this was going to be a test of my skills," she said. "My son had little backpacking experience. I wasn't really nervous, but there was some adrenaline. I was just thinking 'let's put one foot in front of the other' and see how it goes."

They hiked through Cottonwood Pass and the first thing she noticed was how heavy the backpacks were. She had aimed to keep it under 30 pounds, but the pack was closer to 40. It was hot out there, too.

Hiking northbound on the John Muir Trail is generally considered a more difficult route than southbound for one key reason – the altitudes on passes and peaks come early in the hike and make altitude acclimation more critical.

Towry said they were still trying to get their "trail legs" – getting used to the pounding and twisting feet and ankles take on uneven paths over long distances – while also adjusting to the thinner air as they hiked.

Joseph Towry crosses a stream along the John Muir Trail. Photo: Suzanne Towry

But she said they were having fun. Getting the first campsite set up helped them feel like they were on track and the reality of what they were doing began to settle on them. Towry also said they got their first gasp of natural beauty.

"Chicken Springs Lake doesn't look beautiful on the GPS, but when you get there, the water is turquoise," she said. "You start to feel the serenity of nature."

They had a pasta freeze-dried meal. They had also made a decision before leaving that would come back to haunt them later: they packed very few snacks to lighten the weight of their backpacks. That miscue made the freeze-dried meals a less-than-delicious option after days of hiking.

But that first meal was great, she said. At night, the stars filled the sky and a full moon bathed them in a soft glow. They talked through their tents. She thought of Knute and felt both close to him and alone at the same time.

She wondered what the coming days would bring.

Difficult Challenges

The early signs of AMS in Joseph Towry came with feelings of dehydration.

She said they had planned to do about 10 miles that day to get to Rock Creek Lake. Very little of the hike would be flat.

"The thing about the John Muir Trail is you're almost always going up and down," she said. "My son couldn't get that concept. We would work so hard to get up and then go down, only to go up again. He would make comments that made me laugh. He was my comic relief."

But she noticed he was also hot and constantly thirsty. Her experience with search and rescue told her AMS might be setting in. Using a Garmin, which was tracking their progress, she texted a John Muir Trail expert who had helped her plan the journey and told him what was going on. He assured her there was a creek that they could get to where they could get water.

Joseph Towry said he didn't know he was in the early stages of AMS.

"I just figured I wasn't used to all of this," he said. "I noticed that when I got water and food, I felt a little better. It wasn't until the third day that I felt like crap."

Suzanne said she was feeling more comfortable with the surroundings, but by that night, she had chills. It wouldn't be until the next day she'd see why: a serious sunburn had blistered the skin on her arms.

The third day was supposed to be the Whitney day. But the storms were getting closer. The cloud cover made it cooler, but she said they both were taking Advil by then. He noticed she was exhausted and that the sunburns were bothering her.

They also were now in a stretch where they might see only one or two people every few hours. No cell service, either.

Joseph Towry said it became a matter of having no choices.

"My mindset was you can't stop and turn around – there's nowhere to go but forward," he said. "Every day, you just get up and go and sometimes it sucks but you can't really quit. I'd just get myself up and see what my body is capable of."

'Nobody said it was this hard'

They had to get to Bighorn Plateau – a place Knute had said he always wanted to go – and the next day clear 13,200 foot Forester Pass.

But the storm was bearing down and occasional lightning bolts were striking the ground. The problem, she said, was at Bighorn, her and Joseph stood out. Dangerously.

"You don't want to be the tallest object when lighting is striking around," she said. "We had to get to the treeline and I don't think I've ever hiked that fast before."

Suzanne Towry and Joseph Towry were chased by a powerful storm for the first part of their hike. This was a look at the storm clouds forming along the hike. Photo: Suzanne Towry

Her son was starting to recover from the AMS, too. He said he felt dizzy and sometimes at the highest altitudes had the sensation of being in a dreamlike state, but by the time they were able to set up camp, both were alternately pumped up with adrenaline and tired beyond belief.

They were a third of the way into their hike. They'd seen a lot of marmots, some deer and elk and a couple of snakes. At night, she said she heard some twigs snap, but didn't know what it was. Possibly a bear – though she said they never saw one the entire trip.

She said the next day was going to be one of the most challenging days – Center Basin to Kearsarge Lake.

When they started in the morning, it hit her quickly.

"All I kept thinking was, nobody said it was this hard," she said. "At this point, it became our job – to hike all day. But I could also tell our bodies were adapting."

Her arms were sore from the sunburn and she was wearing a long-sleeved covering that irritated the sensitive skin. She had to force herself to eat as the altitude was sapping her appetite. The snacks they hadn't packed would have been helpful now, she thought.

The storm had also touched their campsite again. Lightning had hit right outside their tent, she said. Rain began to pour down. "Torrential downpours," she said. The close call with one lighting strike was especially harrowing. She thought of Knute again and how he used to tease her about her fear of lightning.

Joseph Towry was also unhappy.

He said after Kearsarge Pass, he "never wanted to see another mountain again."

But then they crossed paths with three other women campers at the site. He said they boosted their mood. Empathized with their pain. Listened and agreed with their rants about how miserable it all felt. "They came just at the right time," Joseph Towry said.

Zero Day and Pep Talk

When they started to hike out to get supplies, a search and rescue buddy met them on the trail with a surprise.

"He literally dumped out a bag of snacks and said 'Ta-da!'" Joseph Towry said. "It was M&Ms, peanut butter and candy. It was so, so good."

He said his feet hurt badly and that sometimes each step felt like he was stepping on glass. The two of them fantasized about what kind of meal they'd most want. She said a pizza from a local shop in Mammoth. He craved a Double Western Bacon Cheeseburger with jalapeños from Carl's Jr.

Suzanne Towry said they needed to get off the trail and take a zero day. Zero days are days hikers build into long trips where they rest and recuperate before continuing. They hadn't planned on taking it so soon, but she could tell they both needed it. The storm was also getting worse, too, and she felt it wasn't safe.

Another search and rescue buddy and his wife who had known Knute and Suzanne for a long time drove them to a Motel 6 frequented by hikers. But the rest had another effect she wasn't counting on, either. The comfort of a bed made the discomfort of a sleeping bag and tent all the more real. When it came time to get back on the trail, she wasn't sure she wanted to get back out there again.

Bernie Courville said he rode with them back to the trail and could tell they needed a pep talk.

"I remember when she was a recruit at the academy and she was pushed and got through it," Courville said. "I mainly reminded her of that and how she made it through the challenges with flying colors. I knew she had what it took to get through it."

She said his words really helped her. Her son, she noticed, also seemed ready to go.

Suzanne Towry decided she was ready to get back on the trail. It was tough at first, she said, and she had to push to keep up with her son. It was a long day, but by nightfall, she said she could tell her body was already back to adapting to the new environment.

The pace was also different.

"That first week, we were being chased by a storm and I felt we were always pushing so hard and we hadn't really gotten a chance to do what Knute would have wanted us to do – take in the scenery. To soak in all that was around us. He would have said you don't have to kill yourself to enjoy yourself."

Reflection

She had Knute's ashes with her in a small urn and because of the frenetic pace, she hadn't really had a chance to sit with him along the trail.

Thousand Islands Lake was a picture that was on a binder that she used to have when she'd be with him as he was laid up with cancer. She said seeing the lake motivated him and she knew it was going to be a special place.

It was hot when they saw it – deep blue water, with rocks and sand around it. Small islands dotting the lake and she found a spot to sit and reflect. She took out his ashes.

"Here I am," she said to him. "Here is where we were supposed to be. You're here now."

Suzanne said she could feel his presence, telling her to take it all in and enjoy the moment. To live in the present and not be in such a rush to see what's next.

The weight she had been carrying for days wasn't just in her backpack. It wasn't her tent or her small stove or the fresh snacks or the sleeping bag. It was the weight of grief that had been on her since he died in 2019.

She said in that moment, she realized he always took care of her but she was now out on her own and having to take care of herself. She trusted him and always felt safe with him, no matter where they were. It was different now.

"I have to count on me and that's my new constant," she said.

Back to the World

The pace was no longer breakneck and all of the problems that seemed to have plagued them early weren't issues anymore.

They hiked through Donahue Pass, trod at elevations above 11,000 feet and Joseph showed no signs of AMS. It was hot and windy, but both felt like they were acclimating to a life without business.

Descending down the trail in Yosemite Valley and toward Tuolumne Meadows, they could see vast expanses of green, lined with pine trees and the framing of large rocks that define Yosemite National Park. A river ran through it and she said it glistened in the sunlight like some sort of idyllic photo.

Suzanne Towry and her son kept going, their elevation dropping to about 8,000 feet. She said they began to come across more people who were starting their trek south on the John Muir Trail. As they approached the end, she noticed smoke from a nearby fire.

They had to catch a shuttle to get back to Mammoth, which would then be the place they would head from to eventually go back home to North Carolina. She said the bus driver who picked them up looked at them and told them they needed to wear a mask due to Covid-19 protocols.

She said they had masks in the pack and sat in the bus the entire way. Changed. Different.

Joseph Towry said a day doesn't go by where he doesn't think about the massive clusters of stars he could see on those dark nights and how being on the trail made him think about the big questions of existence and purpose.

Suzanne Towry said the hike brought her clarity after living in a fog with the death of Knute. She said she is more confident now and has plans to do it again. She said she knows Knute is proud of her.

And she knows Mount Whitney will still be there for her return.

On their way to Tyndall Creek on the John Muir Trail. Photo: Suzanne Towry

Exploring Climate Change and Lung Health

Thu, 30 Sep 2021 20:39:39 Z

When you turn on the news or scroll through your social media, it's become a regular occurrence to see the overwhelming effect that climate change is having on the world. Catastrophic events are everywhere, from rampant wildfires, historic heat waves and devastating floods – all directly related to climate change.

In partnership with Axios, Amgen recently hosted an Expert Voices roundtable on climate change and its impact on lung health. Leaders, subject matter experts and policy makers from across disciplines gathered virtually to discuss the widening socioeconomic disparities and how to better prepare for future and long-term effects of climate change on lung health.

Key takeaways from the discussion included:

Climate change is not a problem of tomorrow, it's a problem for today. These issues are becoming more recognized as the impacts start to directly affect larger portions of the population. However, current solutions are a temporary fix. Transitioning from a reactive to a predict and prevent approach can help to curtail the ripple effects of climate change.
Much like COVID-19, many climate change-related health issues first impact the most vulnerable communities. Solutions are needed to alleviate this disproportionate burden on these communities while also considering the existing challenges to resources and access they face.
Wildfire impact has swept across the country, from coast to coast. There's an increase in concentrations of particle matter in the air contributing to poor air quality, which has caused a significant uptick of ER visits for pulmonary issues.
All too often outdoor air quality is the only focus. COVID-19 has put a spotlight on indoor air quality as well. There have been more than 1,000 school closures in 38 states because of air quality issues, which is especially alarming for children's developing lungs.
While there are perceptions that transitioning to more sustainable power approaches are expensive, billions of dollars are spent on the cost of climate change because of the immense damage caused by non-renewable resources and the resulting hospital visits often for respiratory issues.

"It's clear now more than ever that climate change and health, particularly lung health, cannot wait. More than 90% of the global population breathes unhealthy air, a statistic that is only expected to increase on our current trajectory," said roundtable panelist Andrew Lindsley, M.D., Ph.D., medical director and U.S. Medical Affairs Asset Lead at Amgen. "While it was a sobering discussion, there is also hope – as seen through the efforts that my fellow roundtable participants are driving through their respective organizations. A key conclusion from the roundtable is that tackling climate change cannot be done by one group alone, but it will take many perspectives and disciplines to sound the alarm and develop solutions to bring change."

In January of this year, Amgen announced a new environmental sustainability plan that included the goal of achieving carbon neutrality by 2027, as well as a 40% reduction in water used and a 75% reduction in waste disposed.

To read more about the conversation, visit Axios' event recap here.

To read more about Amgen’s ongoing commitment to environmental sustainability, click here.

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